Register of Innovative Drugs

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Products for Human Use

Submission Number	Medicinal Ingredient	Brand Name	Manufacturer	Notice of Compliance Date yyyy-mm-dd	6 Year "No File" Date	Pediatric Extension Yes/No	Data Protection Ends
098531	abatacept	Orencia	Bristol-Myers Squibb Canada	2006-06-29	2012-06-29	Yes	2014-12-29
103287	acamprosate calcium	Campral	Mylan Pharmaceuticals ULC	2007-03-16	2013-03-16		2015-03-16
103381	alglucosidase alfa	Myozyme	Genzyme Canada Inc.	2006-08-14	2012-08-14	Yes	2015-02-14
105388 / 120155	aliskiren hemifumarate / aliskiren hydrochlorothiazide	Rasilez / Rasilez HCT	Novartis Pharmaceuticals Canada Inc.	2007-11-14	2013-11-14		2015-11-14
113287	ambrisentan	Volibris	GlaxoSmithKline Inc.	2008-03-20	2014-03-20		2016-03-20
110202	anidulafungin	Eraxis	Pfizer Canada Inc.	2007-11-14	2013-11-14		2015-11-14
108483	aprepitant	Emend, Emend Tri-Pack	Merck Frosst Canada Ltd.	2007-08-24	2013-08-24		2015-08-24
120192	aripiprazole	Abilify	Bristol-Myers Squibb Canada	2009-07-09	2015-07-09		2017-07-09
127108	azacitidine	Vidaza	Celgene	2009-10-23	2015-10-23		2017-10-23
123400	besifloxacin	Besivance	Bausch & Lomb Inc.	2009-10-23	2015-10-23	Yes	2018-04-23
112752	ceftobiprole medocaril	Zeftera	Janssen-Ortho Inc.	2008-06-26	2014-06-26		2016-06-26
120296	certolizumab pegol	Cimzia	UCB Canada Inc.	2009-08-12	2015-08-12		2017-08-12
101419 /103612	ciclesonide	Alvesco/Omnaris	Nycomed Canada Inc.	2006-09-11	2012-09-11	Yes	2015-03-11
121874	clofarabine	Clolar	Genzyme Canada Inc.	2009-07-16	2015-07-16	Yes	2018-01-16
114887	dabigatran etexilate mesilate	Pradax	Boehringer Ingelheim (Canada) Ltd.	2008-06-10	2014-06-10		2016-06-10
102320	daptomycin	Cubicin	Cubist Pharmaceuticals, Incorporated	2007-09-24	2013-09-24		2015-09-24
103324	darunavir ethanolate	Prezista	Janssen-Ortho Inc.	2006-07-28	2012-07-28	Yes	2015-01-28
104993	dasatinib monohydrate	Sprycel	Bristol-Myers Squibb Canada	2007-03-26	2013-03-26		2015-03-26
099621	deferasirox	Exjade	Novartis Pharmaceuticals Canada Inc.	2006-10-19	2012-10-19	Yes	2015-04-19
120421	degarelix acetate	Firmagon	Ferring Inc.	2009-11-16	2015-11-16		2017-11-16
115439	desvenlafaxine succinate	Pristiq	Wyeth Canada	2009-02-04	2015-02-04		2017-02-04
126931	dexmedetomidine hydrochloride	Precedex	Hospira Healthcare Corporation	2009-12-09	2015-12-09		2017-12-09
113640	doripenem monohydrate	Doribax	Janssen-Ortho Incorporated	2009-09-02	2015-09-02		2017-09-02
121065	dronedarone hydrochloride	Multaq	Sanofi-aventis Canada Inc.	2009-08-11	2015-08-11		2017-08-11
110028	duloxetine hydrochloride	Cymbalta	Eli Lilly Canada Inc.	2007-11-01	2013-11-01		2015-11-01
122467	eculizumab	Soliris	Alexion Pharmaceuticals, Inc.	2009-01-28	2015-01-28		2017-01-28
120440	eplerenone	Inspra	Pfizer Canada Inc.	2009-02-26	2015-02-26		2017-02-26
113100	etravirine	Intelence	Janssen-Ortho Inc.	2008-03-27	2014-03-27		2016-03-27
125809	everolimus	Afinitor	Novartis Pharmaceuticals Canada Inc.	2009-12-14	2015-12-14		2017-12-14
091404	fludeoxyglucose 18F	Cantrace	Ipet Pharmaceuticals Inc.	2006-07-27	2012-07-27		2014-07-27
107372	fluticasone furoate	Avamys	GlaxoSmithKline Inc.	2007-08-14	2013-08-14	Yes	2016-02-14
096420	gadofosveset trisodium	Vasovist	Berlex Canada Inc.	2006-10-31	2012-10-31		2014-10-31
127609	gadoxetate disodium	Primovist	Bayer Inc.	2010-01-14	2016-01-14		2018-01-14
120525	golimumab	Simponi	Centocor Inc.	2009-04-07	2015-04-07		2017-04-07
117672	idebenone	Catena	Santhera Pharmaceuticals Ltd.	2008-07-23	2014-07-23	Yes	2017-01-23
109857	idursulfase	Elaprase	Shire Human Genetic Therapies, Inc.	2007-06-13	2013-06-13	Yes	2015-12-13
098949	lanreotide	Somatuline Autogel	Ipsen Limited	2006-07-17	2012-07-17		2014-07-17
102240	lanthanum carbonate	Fosrenol	Shire BioChem Inc.	2006-10-17	2012-10-17		2014-10-17
110294	lapatinib ditosylate	Tykerb	GlaxoSmithKline Inc.	2009-05-15	2015-05-15		2017-05-15
111952	lenalidomide	Revlimid	Celgene	2008-01-17	2014-01-17		2016-01-17
120534	lisdexamfetamine dimesylate	Vyvanse	Shire Canada Inc.	2009-02-19	2015-02-19	Yes	2017-08-19
117199 / 117231	loteprednol etabonate	Alrex / Lotemax	Bausch & Lomb Inc.	2008-12-23	2014-12-23		2016-12-23
102465	lumiracoxib	Prexige	Novartis Pharmaceuticals Canada Inc.	2006-11-02	2012-11-02		2014-11-02
112435	maraviroc	Celsentri	Pfizer Canada Inc.	2007-09-21	2013-09-21		2015-09-21
106461	methoxy polyethylene gycol epoetin beta	Mircera	Hoffmann-La Roche Ltd.	2008-03-31	2014-03-31		2016-03-31
114266	methylnaltrexone bromide	Relistor	Wyeth Canada	2008-03-28	2014-03-28		2016-03-28
078577	micafungin sodium	Mycamine	Astellas Pharma Canada, Inc.	2007-05-22	2013-05-22		2015-05-22
093001	natalizumab	Tysabri	Biogen Iden Canada Inc.	2006-09-28	2012-09-28		2014-09-28
099994	nelarabine	Atriance	GlaxoSmithKline Inc.	2007-09-22	2013-09-22	Yes	2016-03-22
114004	nepafenac	Nevanac	Alcon Canada Inc.	2008-04-17	2014-04-17		2016-04-17
111760	nesiritide	Natrecor	Janssen-Ortho Inc.	2007-11-08	2013-11-08		2015-11-08
110305	nilotinib hydrochloride monohydrate	Tasigna	Novartis Pharmaceuticals Canada Inc.	2008-09-09	2014-09-09		2016-09-09
115991	olmesartan medoxomil	Olmetec / Olmetec Plus	Schering-Plough Canada Inc.	2008-10-28	2014-10-28		2016-10-28
109965 / 118553	oxaliplatin	Eloxatin	Sanofi-aventis Canada Inc.	2007-06-15	2013-06-15	Yes	2015-12-15
108748	paliperidone	Invega	Janssen-Ortho Inc.	2007-09-26	2013-09-26		2015-09-26
105601	panitumumab	Vectibix	Amgen Canada Inc.	2008-04-03	2014-04-03		2016-04-03
119056	pneumococcal polysaccharide serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F	Synflorix	GlaxoSmithKline Inc.	2008-12-11	2014-12-11	Yes	2017-06-11
122881	pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F	Prevnar 13	Wyeth Canada	2009-12-21	2015-12-21	Yes	2018-06-21
108193	posaconazole	Posanol	Schering-Plough Canada Inc.	2007-03-26	2013-03-26	Yes	2015-09-26
113408	raltegravir potassium	Isentress	Merck Frosst Canada Inc.	2007-11-27	2013-11-27		2015-11-27
110233	ranibizumab	Lucentis	Novartis Opthalmics	2007-06-26	2013-06-26		2015-06-26
101846	rasagiline mesylate	Azilect	Teva Pharmaceuticals Industries Ltd.	2006-08-17	2012-08-17		2014-08-17
102682	recombinant human papillomavirus type 11 L1, type 16 L1, type 18 L1 & type 6 L1 protein	Gardasil	Merck Frosst Canada Ltd.,	2006-07-10	2012-07-10	Yes	2015-01-10
109037	retapamulin	Altargo	GlaxoSmithKline Inc.	2008-03-19	2014-03-19	Yes	2016-09-19
119111	rivaroxaban	Xarelto	Bayer Healthcare	2008-09-15	2014-09-15		2016-09-15
117327	romiplostim	Nplate	Amgen Canada Inc.	2009-02-19	2015-02-19		2017-02-19
109624	rotavirus RIX4414 strain, live, attenuated (human)	Rotarix	GlaxoSmithKline Inc.	2007-10-09	2013-10-09	Yes	2016-04-09
100399	rotavirus vaccine, live, oral type G1, type G2, type G3, type G4 & type P1(8) (human)	Rotateq	Merck Frosst Canada Ltd.	2006-08-01	2012-08-01	Yes	2015-02-01
123854	saxagliptin hydrochloride	Onglyza	Bristol-Myers Squibb Canada	2009-09-14	2015-09-14		2017-09-14
103039 / 123245	sitagliptin phosphate / sitagliptin phosphate	Januvia / Janumet	Merck Frosst Canada Ltd.	2007-12-14	2013-12-14		2015-12-14
101934	sitaxsentan sodium	Thelin	Pfizer Canada Inc.	2007-05-30	2013-05-30		2015-05-30
102070	sorafenib	Nexavar	Bayer Inc.	2006-07-28	2012-07-28		2014-07-28
107792	telavancin hydrochloride	Vibativ	Astellas Pharma Canada Inc.	2009-09-29	2015-09-29		2017-09-29
104469	telbivudine	Sebivo	Novartis Pharmaceuticals Canada Inc.	2006-11-28	2012-11-28		2014-11-28
109201	temsirolimus	Torisel	Wyeth Canada	2007-12-21	2013-12-21		2015-12-21
094870	tigecycline	Tygacil	Wyeth Canada	2006-09-14	2012-09-14		2014-09-14
114272	ustekinumab	Stelara	Janssen-Ortho Inc.	2008-12-12	2014-12-12		2016-12-12
104007	varenicline tartrate	Champix	Pfizer Canada Inc.	2007-01-24	2013-01-24		2015-01-24
104562	vorinostat	Zolinza	Merck Frosst Canada Ltd.	2009-06-11	2015-06-11		2017-06-11
078188	ziprasidone hydrochloride monohydrate	Zeldox	Pfizer Canada Inc.	2007-08-27	2013-08-27		2015-08-27

Products for Veterinary Use

Submission Number	Medicinal Ingredient	Brand Name	Manufacturer	Notice of Compliance Date yyyy-mm-dd	6 Year "No File" Date	Data Protection Ends
110061	cefovecin	Convenia	Pfizer Canada Inc., Animal Health Group	2007-05-30	2013-05-30	2015-05-30
110110	dirlotapide	Slentrol	Pfizer Canada Inc., Animal Health Group	2008-08-14	2014-08-14	2016-08-14
109976	emamectin benzoate	Slice	Intervet Canada Ltd.	2009-06-29	2015-06-29	2017-06-29
112103 / 112106 / 112107	emodepside, praziquantel	Profender	Bayer Healthcare, Animal Health Division	2008-08-28	2014-08-28	2016-08-28
110661 / 110379	firocoxib	Previcox	Merial Canada Inc.	2007-09-28	2013-09-28	2015-09-28
110655 / 110657	ibafloxacin	Ibaflin gel	Intervet Canada Ltd.	2008-01-15	2014-01-15	2016-01-15
110342 / 110344 / 110347 / 110348	maropitant	Cerina	Pfizer Canada Inc., Animal Health Group	2007-09-20	2013-09-20	2015-09-20
111600	miratapide	Yarvitan	Janssen Pharmaceutica N.V	2009-02-20	2015-02-20	2017-02-20
112198 / 112199 / 112202 / 112203 / 112204	spinosad	Comfortis	Elanco, Division Eli Lilly Canada Inc.	2009-08-24	2015-08-24	2017-08-24
123643	toceranib phosphate	Palladia	Pfizer Canada Inc., Animal Health Group	2009-12-01	2015-12-01	2017-12-01
2005171P	tulathromycin	Draxxin	Pfizer Canada Inc., Animal Health Group	2006-08-31	2012-08-31	2014-08-31
110019	zilpaterol hydrochloride	Zilmax	Intervet Canada Ltd.	2009-03-18	2015-03-18	2017-03-18

* The Minister of Health maintains a register of innovative drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.