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Product Monograph Brand Safety Updates

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Product Monograph Brand Safety Updates for Non-Prescription Submissions Cleared in 2014

April 2017

Table - Product Monograph Brand Safety Updates April 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Aclasta 200432 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Act Etidrocal 201597 calcium carbonate, etidronate disodium Actavis Pharma Company N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Act Etidronate 201916 etidronate disodium Actavis Pharma Company N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Aspirin 81 mg, Aspirin 81 mg Quick Chews, Aspirin Regular Strength 202259 acetylsalicylic acid Bayer Inc Consumer Care N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Banzel 194343 rufinamide Eisai Limited N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Biphentin 201555 methylphenidate HCl Purdue Pharma N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Caduet 201169 amlodipine besylate, atorvastatin calcium Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Cardura 201486 doxazosin mesylate Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Depo-Medrol, Depo-Medrol (with preservative) 202516 methylprednisolone acetate Pfizer Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Duodopa 201985 levodopa, carbidopa monohydrate Abbvie Corporation N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Duragesic 202716 fentanyl Janssen Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Eltroxin 201136 levothyroxine sodium Aspen Pharma Trading Limited Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Emend IV 201642 fosaprepitant dimeglumine Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Erivedge 194933 vismodegib Hoffmann La Roche Limited N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Galexos 201947 simeprevir Janssen Inc N/A Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A Product Monograph has been updated
Inspiolto Respimat 196472 tiotropium, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Invokana 194762 canagliflozin Janssen Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jevtana 202244 cabazitaxel Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Metvix 180975 methyl aminolevulinate hydrochloride Galderma Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Mezavant 201889 mesalazine Shire Pharma Canada Ulc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Multihance 188279 gadobenate dimeglumine Bracco Imaging Canada N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Norvir 201368 ritonavir Abbvie Corporation Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Ofev 194900 nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Orkambi 198036 ivacaftor, lumacaftor Vertex Pharmaceuticals (Canada) Incorporated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Pentasa 201731 mesalazine Ferring Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Pomalyst 194902 pomalidomide Celgene Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Precedex 199357 dexmedetomidine HCl Hospira Healthcare Corporation N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Prezcobix 201611 darunavir ethanolate, cobicistat Janssen Inc Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Prezista 201621 darunavir ethanolate Janssen Inc Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Requip 202058 ropinirole hydrochloride Glaxosmithkline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Solu-Medrol, Solu-Medrol Act-O-Vials 202492 methylprednisolone sodium succinate Pfizer Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tobramycin Injection, Tobramycin for Injection 203072 tobramycin Fresenius Kabi Canada Ltd N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Tramacet 201748 acetaminophen, tramadol HCl Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Uptravi 201926 selexipag Actelion Pharmaceuticals Ltd N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A N/A
Valcyte 201550 valganciclovir hydrochloride Hoffmann La Roche Limited Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Viacoram 201871 perindopril arginine, amlodipine Servier Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Yondelis 202008 trabectedin Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Zevtera 201602 ceftobiprole medocaril Basilea Pharmaceutica International Ag N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Zoloft 201862 sertraline HCl Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Zometa 200447 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated

March 2017

Table - Product Monograph Brand Safety Updates March 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Accupril 200979 quinapril HCl Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Accuretic 201238 hydrochlorothiazide, quinapril HCl Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Aclasta 201491 zoledronic acid Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Agrylin 200919 anagrelide hydrochloride monohydrate Shire Pharma Canada Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Airomir 200916 salbutamol sulfate Valeant Canada Lp Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Aptiom 201472 eslicarbazepine acetate Sunovion Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Bonefos 200438 clodronate disodium Bayer Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Busulfex 200963 busulfan Otsuka Pharmaceutical Co Ltd N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Champix 193081 varenicline tartrate Pfizer Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Clasteon 200437 clodronate disodium Sunovion Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Coumadin 200502 warfarin sodium Bristol-Myers Squibb Canada Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A
Coversyl 201008 perindopril erbumine Servier Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Coversyl Plus Ld, Coversyl Plus, Coversyl Plus Hd 201004 perindopril erbumine, indapamide Servier Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Crestor 200016 rosuvastatin calcium Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Cyclen 201124 ethinyl estradiol, norgestimate Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Diane-35 201157 ethinyl estradiol, cyproterone acetate Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Diflucan 200992 fluconazole Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Faslodex 200701 fulvestrant Astrazeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Gelnique 198933 oxybutynin chloride Allergan Pharma Co. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Holkira Pak 201441 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Incruse Ellipta 200693 umeclidinium bromide Glaxosmithkline Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jakavi 198757 ruxolitinib phosphate Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Janumet, Janumet Xr 201792 metformin HCl, sitagliptin phosphate monohydrate Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Januvia 201760 sitagliptin phosphate monohydrate Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Kaletra 201359 ritonavir, lopinavir Abbvie Corporation Product Monograph has been updated N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Narcan Nasal Spray 202248 naloxone HCl Adapt Pharma Operations Limited N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Nidagel 200861 metronidazole Valeant Canada Lp Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Nozinan 200878 methotrimeprazine HCl Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Nuvaring 200891 ethinyl estradiol, etonogestrel Merck Canada Inc N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Ortho 0.5/35 201106 ethinyl estradiol, norethindrone Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Ortho 1/35 201117 ethinyl estradiol, norethindrone Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Ortho 7/7/7 201105 ethinyl estradiol, norethindrone Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Pentamidine Isetionate for Injection, Bp 200751 pentamidine isetionate Hospira Healthcare Corporation N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Pravachol 200020 pravastatin sodium Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Prezista 201394 darunavir ethanolate Janssen Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Primaquine 196046 primaquine phosphate Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A
Renagel 200994 sevelamer hydrochloride Sanofi-Aventis Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Renvela 200973 sevelamer carbonate Sanofi-Aventis Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Revolade 188969 eltrombopag olamine Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Rifadin 200835 rifampin Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Seroquel, Seroquel Xr 200543 quetiapine fumarate Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Signifor 193942 pasireotide Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Stribild 200747 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tarceva 194018 erlotinib hydrochloride Hoffmann La Roche Limited N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Technivie 201487 ritonavir, paritaprevir, ombitasvir Abbvie Corporation Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Tiazac 201438 diltiazem HCl Valeant Canada Lp Valeant Canada S.E.C. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Tiazac Xc 202119 diltiazem HCl Valeant Canada Lp Valeant Canada S.E.C. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Tri-Cyclen 201126 ethinyl estradiol, norgestimate Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Tri-Cyclen Lo 201134 ethinyl estradiol, norgestimate Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Wellbutrin Sr 200957 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Wellbutrin Xl 200959 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Xatral 200961 alfuzosin HCl Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Yasmin 21, Yasmin 28 200941 ethinyl estradiol, drospirenone Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Yasmin Plus 200982 ethinyl estradiol, drospirenone, levomefolate calcium Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Yaz 200938 ethinyl estradiol, drospirenone Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Yaz Plus 201007 ethinyl estradiol, drospirenone, levomefolate calcium Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Zepatier 201181 grazoprevir, elbasvir Merck Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Zeulide Depot 180093 leuprolide acetate Pendopharm Division of Pharmascience Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Zocor 200021 simvastatin Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Zyban 200951 bupropion HCl Valeant Canada Lp Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated

February 2017

Table - Product Monograph Brand Safety Updates February 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Abilify 199169 Aripiprazole Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Anoro Ellipta 198790 Umeclidinium Bromide, Vilanterol Trifenatate Glaxosmithkline Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Apo-ASA LD 200347 Acetylsalicylic Acid Apotex Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Aubagio 200227 Teriflunomide Sanofi Genzyme, A Division of Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Bosulif 200815 Bosutinib Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Clavulin 196916 Amoxicillin, Clavulanic Acid Glaxosmithkline Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Complera 199560 Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Hydrochloride Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Copaxone 200357 Glatiramer Acetate Teva Canada Limited N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Cotellic 199785 Cobimetinib Hoffmann-La Roche Limited N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Evra 200474 Ethinyl Estradiol, Norelgestromin Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Flagyl 200299 Metronidazole Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Flagystatin 200324 Metronidazole, Nystatin Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Harvoni 193140 Ledipasvir, Sofosbuvir Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Heptovir 200536 Lamivudine Glaxosmithkline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Holkira Pak 192833 Ritonavir, Paritaprevir, Ombitasvir, Dasabuvir AbbVie Corporation Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Iclusig 199527 Ponatinib Hydrochloride Ariad Pharmaceuticals Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Imbruvica 192718 Ibrutinib Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Invokamet 199731 Metformin HCl, Canagliflozin Janssen Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jevtana 194950 Cabazitaxel Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A
Levothyroxine Sodium for Injection 197889 Levothyroxine Sodium Fresenius Kabi Canada Ltd Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Lupron Depot 193372 Leuprolide Acetate AbbVie Corporation N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Lysodren 200001 Mitotane Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Micardis Plus 200158 Hydrochlorothiazide, Telmisartan Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Oesclim 199389 Estradiol Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Oxytrol 198930 Oxybutynin Allergan Pharma Co. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A N/A
Prefesta 199390 Estradiol, Norgestimate Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Pristiq 200419 Desvenlafaxine Succinate Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Rapamune 200932 Sirolimus Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Reminyl ER 200217 Galantamine Hydrobromide Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Revlimid 200591 Lenalidomide Celgene Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Tamiflu 199480 Oseltamivir Phosphate Hoffmann-La Roche Limited N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Tecfidera 198810 Dimethyl Fumarate Biogen Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Technivie 192844 Ritonavir, Paritaprevir, Ombitasvir AbbVie Corporation Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tivicay 192462 Dolutegravir Sodium ViiV Healthcare ULC Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Treanda 199858 Bendamustine Hydrochloride Lundbeck Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Triquilar 21, Triquilar 28 200226 Ethinyl Estradiol, Levonorgestrel Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Tybost 200692 Cobicistat Gilead Sciences Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tykerb 199954 Lapatinib Ditosylate Monohydrate Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Videx EC 197051 Didanosine Bristol-Myers Squibb Canada Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Vimpat 193732 Lacosamide UCB Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated

January 2017

Table - Product Monograph Brand Safety Updates January 2017
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Advair, Advair Diskus 199754 fluticasone propionate, salmeterol xinafoate GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Allegra-D 200316 pseudoephedrine HCl, fexofenadine HCl Sanofi-Aventis Canada Inc Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Allopurinol 198729 allopurinol Apotex Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Apo-Bisoprolol 197881 bisoprolol fumarate Apotex Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Butorphanol Nasal Spray 196224 butorphanol tartrate Aa Pharma Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Depakene 200975 valproic acid BGP Pharma Ulc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Docetaxel Injection Usp 199491 docetaxel Hospira Healthcare Corporation N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Epival 201016 divalproex sodium BGP Pharma Ulc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Esbriet 199306 pirfenidone Hoffmann La Roche Limited N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Gleevec 199774 imatinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Imbruvica 199713 ibrutinib Janssen Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Invokamet 198711 metformin HCl, canagliflozin Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Invokana 198712 canagliflozin Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jadenu 194474 deferasirox Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Jardiance 198914 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Lipidil Ez 198956 fenofibrate BGP Pharma Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Lipidil Supra 198973 fenofibrate BGP Pharma Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Marvelon 21, Marvelon 28 199319 desogestrel, ethinyl estradiol Merck Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Nersione 200095 diflucortolone valerate GlaxoSmithKline Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Nuvaring 199249 ethinyl estradiol, etonogestrel Merck Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Prevacid, Prevacid Fastab 200287 lansoprazole Takeda Pharmaceuticals America Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Rupall 199706 rupatadine fumarate Pediapharm Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Sunvepra 199423 asunaprevir Bristol-Myers Squibb Canada Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Synjardy 199955 metformin HCl, empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Telzir 198633 fosamprenavir Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Tramacet 196229 acetaminophen, tramadol HCl Janssen Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Ultram 196230 tramadol HCl Janssen Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Zelboraf 192354 vemurafenib Hoffmann La Roche Limited N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Zyloprim 198730 allopurinol Aa Pharma Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated

December 2016

Product Monograph Brand Safety Updates December 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
3TC 197792 lamivudine Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Abilify Maintena 198294 aripiprazole Otsuka Pharmaceutical Co Ltd N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Adempas 198385 riociguat Bayer Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Amaryl 198596 glimepiride Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Amiodarone Hydrochloride For Injection, Amiodarone Syringe 198348 amiodarone HCl Sandoz Canada Incorporated N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Arcosyl Plus, Arcosyl Plus Ld 197114 indapamide, perindopril arginine Servier Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Atripla 198437 efavirenz, emtricitabine, tenofovir disoproxil fumarate Bristol-Myers Squibb And Gilead Sciences Llc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Burinex 199138 bumetanide Leo Pharma Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Caprelsa 198802 vandetanib Sanofi Genzyme, A Division Of Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Caripul 197550 epoprostenol sodium Actelion Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Clindamycin IV Infusion 197403 clindamycin phosphate Sandoz Canada Incorporated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Combivir 197907 zidovudine, lamivudine Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Depo-Provera 198801 medroxyprogesterone acetate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Dexilant 197719 dexlansoprazole Takeda Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Duratocin 190823 carbetocin Ferring Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Durela 196227 tramadol HCl Cipher Pharmaceuticals Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Exjade 191351 deferasirox Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Ferrlecit 195781 sodium ferric gluconate complex in sucrose injection Sanofi-Aventis Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Forxiga 198838 dapagliflozin Astrazeneca Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Fycompa 194525 perampanel Eisai Limited N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Genvoya 198272 emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide hemifumarate Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Gilenya 198247 fingolimod hydrochloride Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Hp-Pac 197727 amoxicillin, clarithromycin, lansoprazole Takeda Pharmaceuticals America Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Imodium Calming Liquid, Imodium Caplets, Imodium Liqui-Gels, Imodium Quick Dissolve 198609 loperamide HCl Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Imodium Complete Caplets, Imodium Complete Chewable Tablets 198510 loperamide HCl, simethicone Mcneil Consumer Healthcare Division Of Johnson & Johnson Inc N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Istodax 199398 romidepsin Celgene Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Jentadueto 198478 metformin HCl, linagliptin Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Kivexa 197786 lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Kyprolis 194999 carfilzomib Amgen Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Lotensin 197116 benazepril HCl Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A N/A
Lyrica 198215 pregabalin Pfizer Canada Inc N/A N/A N/A N/A N/A N/A Product Monograph has been updated N/A
Mekinist 197849 trametinib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Methotrexate 198792 methotrexate sodium Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A N/A
Movantik 198089 naloxegol oxalate Astrazeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Neurontin 198809 gabapentin Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Olmetec 198091 olmesartan  medoxomil Merck Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Olmetec Plus 198164 hydrochlorothiazide, olmesartan  medoxomil Merck Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Panto IV 197721 pantoprazole sodium sesquihydrate Takeda Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Pantoloc 197723 pantoprazole Takeda Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Pariet 197710 rabeprazole Janssen Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Plavix 199386 clopidogrel bisulfate Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Ralivia 196236 tramadol HCl Valeant Canada Lp Valeant Canada S.E.C. Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Remeron 197879 mirtazapine Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Remeron Rd 197936 mirtazapine Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Retrovir (Azt) 197908 zidovudine Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Revlimid 190743 lenalidomide Celgene Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Serophene 189606 clomiphene citrate Emd Serono Z Division Of Emd Inc Canada Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A
Sonovue 189455 sulfur hexafluoride Bracco Imaging Canada Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Suboxone 195433 buprenorphine hydrochloride, naloxone hydrochloride dihydrate Indivior Uk Limited Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Tafinlar 197867 dabrafenib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Tecta 197724 pantoprazole magnesium Takeda Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Topamax 198204 topiramate Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Torisel 199380 temsirolimus Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Trajenta 198479 linagliptin Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Tridural 196232 tramadol HCl Paladin Labs Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Triumeq 197843 lamivudine, abacavir sulfate, dolutegravir sodium Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Trizivir 197841 zidovudine, lamivudine, abacavir sulfate Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Ultibro Breezhaler 198299 glycopyrronium bromide, indacaterol maleate Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Viacoram 198962 perindopril arginine, amlodipine Servier Canada Inc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Vimpat 198678 lacosamide Ucb Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Votrient 198325 pazopanib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Xalkori 198487 crizotinib Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Xigduo 198902 metformin HCl, dapagliflozin Astrazeneca Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Ziagen 197787 abacavir sulfate Viiv Healthcare Ulc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Zocor 197663 simvastatin Merck Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Zocor 199039 simvastatin Merck Canada Inc Product Monograph has been updated N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Zyprexa, Zyprexa Zydis, Zyprexa Intramuscular 198327 olanzapine, olanzapine tartrate Eli Lilly Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zytram XL 196235 tramadol HCl Purdue Pharma Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated

November 2016

Product Monograph Brand Safety Updates November 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Accutane Roche 198170 isotretinoin Hoffmann La Roche Limited N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Adcirca 197483 tadalafil Eli Lilly Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Amerge 195190 naratriptan HCl GlaxoSmithKline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Apo-Doxy, Apo-Doxy-Tabs 194708 doxycycline hyclate Apotex Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Arcosyl 197113 perindopril arginine Servier Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Casodex 198469 bicalutamide Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Cialis 197461 tadalafil Eli Lilly Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Codeine Contin 196233 codeine sulfate Purdue Pharma Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Cubicin 197629 daptomycin Cubist Pharmaceuticals LLC N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Cysview 193861 hexaminolevulinate hydrochloride Biosyent Pharma Inc N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Daklinza 189820 daclatasvir Bristol-Myers Squibb Canada Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Dexilant 194184 dexlansoprazole Takeda Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Diabeta 197357 glyburide Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Dilaudid HP 195097 hydromorphone HCl Purdue Pharma Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Erivedge 196987 vismodegib Hoffmann La Roche Limited Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Faslodex 197757 fulvestrant Astrazeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A
Fibristal 190760 ulipristal acetate Actavis Specialty Pharmaceuticals Co N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Flagyl 197442 metronidazole Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Flagystatin 197434 metronidazole, nystatin Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Galexos 190665 simeprevir Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Holkira Pak 190518 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Intralipid 10%, Intralipid 20%, Intralipid 30% 196682 soybean oil Fresenius Kabi Canada Ltd Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A
Iopidine 197019 apraclonidine HCl Alcon Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Losec 197703 omeprazole, omeprazole magnesium Astrazeneca Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Marvelon 197331 desogestrel, ethinyl estradiol Merck Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Mavik 197753 trandolapril BGP Pharma ULC N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Movantik 193483 naloxegol Astrazeneca Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Nexium 197707 esomeprazole Astrazeneca Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Nuvaring 197333 ethinyl estradiol, etonogestrel Merck Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Ofev 196957 nintedanib Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Paxil 195493 paroxetine HCl GlaxoSmithKline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Paxil CR 195495 paroxetine HCl GlaxoSmithKline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Picato 198249 ingenol mebutate Leo Pharma Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Plan B 190655 levonorgestrel Teva Branded Pharmaceutical Products R&D Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Revolade 198151 eltrombopag olamine Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Saphris 190584 asenapine Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Signifor Lar 189699 pasireotide Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A
Talwin 195187 pentazocine HCl Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Technivie 197870 ritonavir, paritaprevir, ombitasvir Abbvie Corporation Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A N/A
Thalomid 198336 thalidomide Celgene Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Tobramycin Injection 197545 tobramycin Fresenius Kabi Canada Ltd N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Toloxin 196770 digoxin Pendopharm Division of Pharmascience Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Treanda 188195 bendamustine hydrochloride Lundbeck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Vidaza 197742 azacitidine Celgene Corporation N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Vimovo 197709 naproxen, esomeprazole magnesium trihydrate Astrazeneca Canada Inc N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated

October 2016

Product Monograph Brand Safety Updates October 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Abilify Maintena 188748 aripiprazole Otsuka Pharmaceutical Co Ltd N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Abstral 194811 fentanyl citrate Paladin Labs Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Cardizem CD 196868 diltiazem HCl Valeant Canada LP Valeant Canada S.E.C. Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Champix 188898 varenicline tartrate Pfizer Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Clindets 192195 clindamycin GlaxoSmithKline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Clozaril 196471 clozapine HLS Therapeutics Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Depakene 197328 valproic acid BGP Pharma ULC N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Diamicron 197558 gliclazide Servier Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A N/A
Diamicron MR 197557 gliclazide Servier Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Digoxin Injection C.S.D., Pediatric Digoxin Injection C.S.D. 196778 digoxin Sandoz Canada Incorporated N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Dilaudid 195096 hydromorphone HCl Purdue Pharma Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Eligard 196408 leuprolide acetate Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A
Epival 196507 divalproex sodium BGP Pharma ULC N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Fentanyl Citrate Injection USP 194813 fentanyl citrate Hospira Healthcare Corporation Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Fentora 194812 fentanyl citrate Teva Canada Limited Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Forane 194452 isoflurane Baxter Corporation N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Holkira PAK 197939 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie Corporation Product Monograph has been updated N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Invokamet 196792 metformin HCl, canagliflozin Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Invokana 196794 canagliflozin Janssen Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Janumet, Janumet XR 189405 metformin HCl, sitagliptin phosphate monohydrate Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Januvia 189383 sitagliptin phosphate monohydrate Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Juxtapid 194945 lomitapide mesylate Aegerion Pharmaceuticals Canada Ltd N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Kuvan 186959 sapropterin dihydrochloride Biomarin Pharmaceutical Inc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Lamictal 194353 lamotrigine GlaxoSmithKline Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A N/A
Megace OS 195954 megestrol acetate Bristol-Myers Squibb Canada N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Naproxen Liquid Gel Capsules 197381 naproxen, naproxen sodium Mcneil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Natesto 195395 testosterone Acerus Pharmaceuticals SRL N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Nucynta IR 195181 tapentadol hydrochloride Janssen Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Oxy.IR 194806 oxycodone HCl Purdue Pharma Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Remeron 193516 mirtazapine Merck Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Remeron RD 193523 mirtazapine Merck Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Rythmodan 196675 disopyramide Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A
Stribild 196911 emtricitabine, tenofovir disoproxil fumarate, elvitegravir, cobicistat Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Truvada 196830 emtricitabine, tenofovir disoproxil fumarate Gilead Sciences Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Viracept 197422 nelfinavir mesylate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Viread 196890 tenofovir disoproxil fumarate Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Voltaren Emulgel Joint Pain 196570 diclofenac diethylamine GlaxoSmithKline Consumer Healthcare Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Voltaren Emulgel, Voltaren Emulgel Extra Strength 196568 diclofenac diethylamine GlaxoSmithKline Consumer Healthcare Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Xeljanz 197115 tofacitinib Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Xyrem 196511 sodium oxybate Valeant Canada LP Valeant Canada S.E.C. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated

September 2016

Product Monograph Brand Safety Updates September 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Afinitor 188334 everolimus Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Bosulif 195997 bosutinib Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Canesten Comfortab 3 188128 clotrimazole Bayer Inc Consumer Care N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Clasteon 195971 clodronate disodium Sunovion Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Clolar 195475 clofarabine Sanofi-Aventis Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Depo-Medrol (with preservative), Depo-Medrol 193764 methylprednisolone acetate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Depo-Medrol with Lidocaine 193798 lidocaine HCl, methylprednisolone acetate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Dilantin 196056 phenytoin sodium Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Dilantin - 30 Suspension, Dilantin - 125 Suspension, Dilantin Infatabs 196033 phenytoin Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Edarbyclor 195494 chlorthalidone, azilsartan medoxomil Valeant Canada LP Valeant Canada S.E.C. Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Entrophen, Entrophen Chewable, Entrophen 325 mg Tablets, Entrophen 325 mg Caplets 191533 acetylsalicylic acid Pendopharm Division of Pharmascience Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Extraneal 195522 calcium chloride, magnesium chloride, sodium chloride, sodium lactate, icodextrin Baxter Corporation N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Famvir 196268 famciclovir Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Faslodex 195194 fulvestrant Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Imbruvica 194722 ibrutinib Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jardiance 196523 empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Keppra 195211 levetiracetam UCB Canada Inc N/A N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Komboglyze 195708 metformin HCl, saxagliptin Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Lasix Oral Solution 196514 furosemide Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lasix Special 196515 furosemide Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Metvix 193502 methyl aminolevulinate hydrochloride Galderma Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Nighttime Cold, Cough And Flu 192563 diphenhydramine HCl, ibuprofen Apotex Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Novo-Salbutamol HFA 189999 salbutamol sulfate Teva Canada Limited Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Onglyza 195704 saxagliptin Astrazeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Pomalyst 195645 pomalidomide Celgene Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Prefesta 194575 estradiol, norgestimate Searchlight Pharma Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Reyataz 196912 atazanavir sulfate Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Sandostatin LAR 196642 octreotide acetate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Seebri Breezhaler 196095 glycopyrronium bromide Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Solu-Medrol 194272 methylprednisolone hemisuccinate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Tecfidera 196304 dimethyl fumarate Biogen Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A
Thalomid 180988 thalidomide Celgene Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A
Travatan Z 196444 travoprost Alcon Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Vfend 196793 voriconazole Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Voltaren Ophtha 193966 diclofenac sodium Alcon Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Vyvanse 181720 lisdexamfetamine dimesylate Shire Pharma Canada ULC N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Xtandi 188577 enzalutamide Astellas Pharma Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Yondelis 194563 trabectedin Janssen Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zydelig 194004 idelalisib Gilead Sciences Canada Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Zykadia 194492 ceritinib Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A N/A

August 2016

Product Monograph Brand Safety Updates August 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Avelox, Avelox IV 194225 Moxifloxacin Hydrochloride Bayer Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A
Azopt 195439 Brinzolamide Alcon Canada Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Butrans 194686 Buprenorphine Purdue Pharma N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Cardura 195152 Doxazosin Mesylate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Ciprodex 195747 Dexamethasone, Ciprofloxacin Alcon Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Copaxone 186047 Glatiramer Acetate Teva Canada Limited N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Coversyl Plus 187041 Perindopril Erbumine, Indapamide Servier Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Cytosar 194840 Cytarabine Pfizer Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Entresto 195332 Valsartan, Sacubitril Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Estragyn Vaginal Cream 195579 Estrone Searchlight Pharma Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Evotaz 195706 Atazanavir Sulfate, Cobicistat Bristol-Myers Squibb Canada Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Ferrlecit 195206 Sodium Ferric Gluconate Complex in Sucrose Injection Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Flonase 194417 Fluticasone Propionate Glaxosmithkline Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Forxiga 194091 Dapagliflozin AstraZeneca Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Giotrif 187656 Afatinib Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Gleevec 195215 Imatinib Mesylate Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Inomax 195633 Nitric Oxide INO Therapeutics N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Invokana 194078 Canagliflozin Janssen Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jardiance 194090 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lenvima 194919 Lenvatinib Mesylate Eisai Limited N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lescol, Lescol XL 195234 Fluvastatin Sodium Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Medrol 193759 Methylprednisolone Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Mefloquine 192237 Mefloquine HCl AA Pharma Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Monurol 193809 Fosfomycin Tromethamine Paladin Labs Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Norvasc 195429 Amlodipine Besylate Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Pradaxa 194941 Dabigatran Etexilate Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated
Prezista 188263 Darunavir Ethanolate Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Prinivil 194510 Lisinopril Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Pristiq 194783 Desvenlafaxine Succinate Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Prometrium 194573 Progesterone Merck Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Sensipar 194491 Cinacalcet Hydrochloride Amgen Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Signifor LAR 194062 Pasireotide Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Singulair 195377 Montelukast Sodium Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Solu-Medrol, Solu-Medrol Act-O-Vials 195651 Methylprednisolone Sodium Succinate Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Sprycel 195287 Dasatinib Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Symbicort Turbuhaler 194760 Budesonide, Formoterol Fumarate Dihydrate AstraZeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Tasigna 195243 Nilotinib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Xalatan 195072 Latanoprost Pfizer Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Xeloda 194861 Capecitabine Hoffmann-La Roche Limited N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Xigduo 194093 Metformin HCl, Dapagliflozin AstraZeneca Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zerbaxa 195705 Tazobactam Sodium, Ceftolozane Sulfate Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zoladex, Zoladex LA 194119 Goserelin Acetate AstraZeneca Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Zometa Concentrate 194820 Zoledronic Acid Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zyban 194844 Bupropion HCl Valeant Canada LP Valeant Canada S.E.C. N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Zytiga 191178 Abiraterone Acetate Janssen Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated

July 2016

Product Monograph Brand Safety Updates July 2016
Brand Name Submission Number IngredientManufacturerContra-indicationsWarning and PrecautionsSerious Warnings and Precautions BoxAdverse ReactionsDrug InteractionsDosage and AdministrationOverdosageConsumer Information
Adalat XL 194331 Nifedipine Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Allegra-D 194147 Pseudoephedrine HCl, Fexofenadine HCl Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Bactroban 194465 Mupirocin GlaxoSmithKline Consumer Healthcare Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Bactroban Cream 194464 Mupirocin GlaxoSmithKline Consumer Healthcare Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Caelyx 194526 Doxorubicin HCl Janssen Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Caprelsa 194111 Vandetanib Astrazeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Celebrex 187485 Celecoxib Pfizer Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Cisplatin Injection 194668 Cisplatin Hospira Healthcare Corporation N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A
Claritin Kids 190569 Loratadine Bayer Inc Consumer Care N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Complera 194358 Emtricitabine, Tenofovir Disoproxil Fumarate, Rilpivirine Hydrochloride Gilead Sciences Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Conray 30, Conray 43, Conray 60 195030 Iothalamate Meglumine Leiner Health Products Inc, Liebel-Flarsheim Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Cymbalta 192853 Duloxetine HCl Eli Lilly Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Diamicron 193245 Gliclazide Servier Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Diamicron MR 193244 Gliclazide Servier Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Effexor XR 192644 Venlafaxine HCl Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Exelon 194254 Rivastigmine Hydrogen Tartrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A N/A
Exelon Patch 194302 Rivastigmine Novartis Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Flarex 193208 Fluorometholone Acetate Alcon Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Heptovir 196237 Lamivudine GlaxoSmithKline Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
HP-Pac 194123 Amoxicillin, Clarithromycin, Lansoprazole Takeda Pharmaceuticals America Inc Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Imbruvica 190730 Ibrutinib Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Jadenu 194378 Deferasirox Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Janumet, Janumet XR 195266 Metformin HCl, Sitagliptin Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Januvia 195337 Sitagliptin Phosphate Monohydrate Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Jardiance 190736 Empagliflozin Boehringer Ingelheim (Canada) Ltd Ltee N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Kaletra 187436 Ritonavir, Lopinavir Abbvie Corporation Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Lasix Oral Solution 193797 Furosemide Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lasix Special 193757 Furosemide Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Losec 194504 Omeprazole, Omeprazole Magnesium AstraZeneca Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated
Luvox 192638 Fluvoxamine Maleate BGP Pharma ULC N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Mepron 188021 Atovaquone GlaxoSmithKline Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A N/A
Methotrexate 186635 Methotrexate Sodium Pfizer Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Nitroglycerin in 5% Dextrose Injection 192761 Nitroglycerin, Dextrose Anhydrous Baxter Corporation Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A
Norvir 187473 Ritonavir Abbvie Corporation Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Pediapred 194274 Prednisolone Phosphate Sodium Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Pediapred 194862 Prednisolone Sodium Phosphate Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Pepcid Complete 194117 Calcium Carbonate, Famotidine, Magnesium Hydroxide McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Pristiq 192643 Desvenlafaxine Succinate Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Prozac 192639 Fluoxetine HCl Eli Lilly Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Reactine Complete 192151 Cetirizine Hydrochloride, Pseudoephedrine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A Product Monograph has been updatedN/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Revolade 194226 Eltrombopag Olamine Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Saphris 186897 Asenapine Merck Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/AProduct Monograph has been updated N/A Product Monograph has been updated
Selexid 178013 Pivmecillinam HCl Leo Pharma Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Sovaldi 192837 Sofosbuvir Gilead Sciences Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Staxyn 195312 Vardenafil Hydrochloride Bayer Inc Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Striverdi Respimat 191601 Olodaterol Hydrochloride Boehringer Ingelheim (Canada) Ltd Ltee N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Tarceva 194541 Erlotinib Hydrochloride Hoffmann-La Roche Limited N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Tenoretic 190685 Atenolol, Chlorthalidone AstraZeneca Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tenormin 190682 Atenolol AstraZeneca Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Tobradex 194015 Dexamethasone, Tobramycin Alcon Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Trelstar 189866 Triptorelin Pamoate Allergan Pharma Co. N/A N/A N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Trosec 193424 Trospium Chloride Sunovion Pharmaceuticals Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Yondelis 193606 Trabectedin Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Zantac Tab 75 mg, Zantac Maximum Strength Non-Prescription Tablets 194126 Ranitidine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Zepatier 193658 Grazoprevir, Elbasvir Merck Canada Inc Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Zithromax 192780 Azithromycin Dihydrate Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Zoloft 192642 Sertraline HCl Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Zyban 192854 Bupropion HCl Valeant Canada LP Valeant Canada S.E.C. N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated

June 2016

Product Monograph Brand Safety Updates July 2016
Brand Name Submission Number IngredientManufacturerContra-indicationsWarning and PrecautionsSerious Warnings and Precautions BoxAdverse ReactionsDrug InteractionsDosage and AdministrationOverdosageConsumer Information
Activelle 193378 norethindrone acetate, estradiol hemihydrate Novo Nordisk Canada Inc N/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated Product Monograph has been updated
Activelle LD 193505 norethindrone acetate, estradiol hemihydrate Novo Nordisk Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Advair, Advair Diskus 185411 fluticasone propionate, salmeterol xinafoate GlaxoSmithKline Inc Product Monograph has been updated Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Alomide 192491 lodoxamide tromethamine Alcon Canada Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Anandron 193850 nilutamide Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Apo-Bisoprolol 190664 bisoprolol fumarate Apotex IncN/AN/AN/AN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated
Busulfex 190897 busulfan Otsuka Pharmaceutical Co LtdN/A Product Monograph has been updatedN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updatedN/AN/A
Caverject 193414 alprostadil Pfizer Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Celexa 192636 citalopram hydrobromide Lundbeck Canada IncN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Cipralex 192637 escitalopram oxalate, escitalopram Lundbeck Canada IncN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Combivent Respimat 192183 ipratropium bromide, salbutamol Boehringer Ingelheim (Canada) Ltd LteeN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Concerta 195814 methylphenidate HCl Janssen Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Dalacin C 192185 clindamycin HCl Pfizer Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Dalacin C Phosphate 192190 clindamycin phosphate Pfizer Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Dalacin T 192193 clindamycin phosphate Pfizer Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Dalacin Vaginal Cream 192194 clindamycin phosphate Pfizer Canada IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Depo-Provera, Depo-Provera - SC 191629 medroxyprogesterone acetate Pfizer Canada IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Duodopa 193087 levodopa, carbidopa monohydrate Abbvie CorporationN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Eliquis 184464 apixaban Bristol-Myers Squibb CanadaN/AN/AN/AN/AN/A Product Monograph has been updatedN/A Product Monograph has been updated
Flovent Diskus, Flovent HFA 185395 fluticasone propionate GlaxoSmithKline Inc Product Monograph has been updated Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Harvoni 190246 ledipasvir, sofosbuvir Gilead Sciences Canada Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updated
Holkira Pak 192923 ritonavir, paritaprevir, ombitasvir, dasabuvir Abbvie CorporationN/AN/AN/AN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated
Inspiolto Respimat 191398 tiotropium bromide monohydrate, olodaterol hydrochloride Boehringer Ingelheim (Canada) Ltd LteeN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Intuniv XR 193758 guanfacine HCl Shire Pharma Canada ULCN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updated
Invega Trinza 185929 paliperidone palmitate Janssen Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Invokana 193242 canagliflozin Janssen IncN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Jardiance 192785 empagliflozin Boehringer Ingelheim (Canada) Ltd LteeN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Jevtana 193235 cabazitaxel Sanofi-Aventis Canada Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated Product Monograph has been updated
Latisse 193534 bimatoprost Allergan IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Myrbetriq 192447 mirabegron Astellas Pharma Canada IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Nadolol 190672 nadolol Aa Pharma IncN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Oxeze Turbuhaler 185400 formoterol fumarate dihydrate Astrazeneca Canada IncN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Periolimel 2.5% E, Olimel 3.3%E, Olimel 4.4%, Olimel 4.4% E, Olimel 5.7%, Olimel 5.7% E 193319 alanine, l-aspartic acid, dextrose, calcium chloride, glutamic acid, glycine, histidine, l-arginine, l-isoleucine, l-leucine, l-phenylalanine, l-proline, l-threonine, l-valine, lysine acetate, magnesium chloride,  l-methionine, olive oil, potassium chloride, serine, sodium glycerophosphate, soybean oil, tryptophan, l-tyrosine, sodium acetate trihydrate Baxter CorporationN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updated
Picato 191625 ingenol mebutate Leo Pharma IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Precedex 192779 dexmedetomidine HCl Hospira Healthcare CorporationN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Rasilez 192713 aliskiren fumarate Novartis Pharmaceuticals Canada IncN/AN/AN/AN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated
Rasilez HCT 192711 hydrochlorothiazide, aliskiren fumarate Novartis Pharmaceuticals Canada IncN/AN/AN/AN/AN/AN/AN/A Product Monograph has been updated
Revolade 192244 eltrombopag olamine Novartis Pharmaceuticals Canada IncN/A Product Monograph has been updatedN/AN/AN/AN/AN/A Product Monograph has been updated
Rhinocort Aqua 192246 budesonide Astrazeneca Canada Inc Product Monograph has been updated Product Monograph has been updatedN/AN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Spiriva Respimat 191395 tiotropium bromide monohydrate Boehringer Ingelheim (Canada) Ltd LteeN/AN/AN/AN/A Product Monograph has been updatedN/AN/AN/A
Technivie 192731 ritonavir, paritaprevir, ombitasvir Abbvie CorporationN/AN/AN/AN/A Product Monograph has been updatedN/AN/A Product Monograph has been updated
Tivicay 195180 dolutegravir sodium Viiv Healthcare ULCN/AN/AN/AN/AN/A Product Monograph has been updatedN/AN/A
Trandate 190689 labetalol HCl Paladin Labs IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/A Product Monograph has been updated
Uptravi 193755 selexipag Actelion Pharmaceuticals Ltd Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updated
Vancocin 182113 vancomycin Merus Labs International Inc Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updated
Voltaren Rapide 193384 diclofenac potassium Novartis Pharmaceuticals Canada IncN/AN/AN/A Product Monograph has been updatedN/AN/AN/AN/A
Voltaren, Voltaren SR 193614 diclofenac sodium Novartis Pharmaceuticals Canada IncN/AN/AN/AN/AN/AN/AN/A Product Monograph has been updated
Vyvanse 194040 lisdexamfetamine dimesylate Shire Pharma Canada ULCN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updated
Yaz 189056 ethinyl estradiol, drospirenone Bayer IncN/A N/A N/A N/AN/A N/AN/A Product Monograph has been updated
Zytiga 192721 abiraterone acetate Janssen IncN/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updatedN/A Product Monograph has been updatedN/A Product Monograph has been updated

May 2016

Table - Product Monograph Brand Safety Updates May 2016
Brand Name Submission Number Ingredient Manufacturer Contra-indications Warning and Precautions Serious Warnings and Precautions Box Adverse Reactions Drug Interactions Dosage and Administration Overdosage Consumer Information
Afinitor 188629 everolimus Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Apo-Zidovudine-Lamivudine-Nevirapine 193373 zidovudine, lamivudine, nevirapine Apotex Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Atarax Syrup 183332 hydroxyzine HCl Erfa Canada 2012 Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Biaxin, Biaxin XL, Biaxin Bid 191336 clarithromycin BGP Pharma ULC Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Brevibloc Injection, Brevibloc Premixed Injection 190667 esmolol HCl Baxter Corporation N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Brilinta 184666 ticagrelor AstraZeneca Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Bystolic 190670 nebivolol HCl Forest Laboratories Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Cancidas 192019 caspofungin acetate Merck Canada Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Colchicine 190129 colchicine Odan Laboratories Ltd N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A
Concerta 185399 methylphenidate HCl Janssen Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Coumadin 191315 warfarin sodium Bristol-Myers Squibb Canada N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Cyclomen 191891 danazol Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A N/A N/A
Daklinza 189173 daclatasvir Bristol-Myers Squibb Canada N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Edurant 185031 rilpivirine hydrochloride Janssen Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Ella 188121 ulipristal acetate Laboratoire HRA Pharma N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Esbriet 184128 pirfenidone Hoffmann La Roche Limited N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Extra Strength Tylenol Nighttime 192759 acetaminophen, diphenhydramine HCl McNeil Consumer Healthcare Division of Johnson & Johnson Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated
Finacea 192498 azelaic acid Bayer Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Forxiga 191977 dapagliflozin AstraZeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Iclusig 191981 ponatinib hydrochloride Ariad Pharmaceuticals Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Inderal-La 190671 propranolol HCl Pfizer Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Jalyn 190261 tamsulosin hydrochloride, dutasteride GlaxoSmithKline Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lamisil 192408 terbinafine HCl Novartis Pharmaceuticals Canada Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Latuda 189779 lurasidone hydrochloride Sunovion Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Lincocin 192468 lincomycin HCl Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A N/A N/A N/A Product Monograph has been updated
Lopresor 190663 metoprolol tartrate Novartis Pharmaceuticals Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Lumigan RC 193230 bimatoprost Allergan Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Lutrepulse 187199 gonadorelin acetate Ferring Inc N/A N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Mekinist 185328 trametinib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Motrimax 12 Hour Back & Body 192978 naproxen, naproxen sodium McNeil Consumer Healthcare Division of Johnson & Johnson Inc N/A N/A N/A N/A N/A N/A N/A Product Monograph has been updated
Myfortic 190737 mycophenolate sodium Novartis Pharmaceuticals Canada Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
PMS-Carvedilol 190681 carvedilol Pharmascience Inc Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Posanol 192829 posaconazole Merck Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated N/A N/A
Primaquine 192430 primaquine phosphate Sanofi-Aventis Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A N/A Product Monograph has been updated Product Monograph has been updated
Tafinlar 185149 dabrafenib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Taxotere 192429 docetaxel Sanofi-Aventis Canada Inc N/A N/A N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated
Temodal 192796 temozolomide Merck Canada Inc N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated
Tobradex 193340 dexamethasone, tobramycin Alcon Canada Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Tobrex, Tobrexan 193426 tobramycin Alcon Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Tramacet 190825 acetaminophen, tramadol HCl Janssen Inc Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated
Vagifem 10 192241 estradiol hemihydrate Novo Nordisk Canada Inc Product Monograph has been updated Product Monograph has been updated N/A N/A N/A N/A Product Monograph has been updated Product Monograph has been updated
Vigamox 192490 moxifloxacin hydrochloride Alcon Canada Inc N/A Product Monograph has been updated N/A N/A N/A Product Monograph has been updated N/A Product Monograph has been updated
Viracept 190648 nelfinavir mesylate Pfizer Canada Inc N/A Product Monograph has been updated N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Viskazide 190706 hydrochlorothiazide, pindolol Tribute Pharmaceuticals Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A Product Monograph has been updated
Visken 190690 pindolol Tribute Pharmaceuticals Canada Inc N/A N/A N/A N/A Product Monograph has been updated N/A N/A N/A
Xigduo 191838 metformin HCl, dapagliflozin AstraZeneca Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated
Zeldox 192415 ziprasidone hydrochloride monohydrate Pfizer Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated Product Monograph has been updated N/A Product Monograph has been updated
Zovirax 191703 acyclovir GlaxoSmithKline Inc N/A N/A N/A N/A N/A Product Monograph has been updated N/A N/A
Zykadia 185683 ceritinib Novartis Pharmaceuticals Canada Inc N/A Product Monograph has been updated N/A Product Monograph has been updated Product Monograph has been updated N/A N/A Product Monograph has been updated