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Access to Information Requests Completed - September 2010

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The following is a list of Access to Information requests processed by Health Canada. The list is not all-inclusive. Requests such as those that did not result in the release of any records or that contain primarily personal information are not posted.

If you wish to obtain a copy of the records released in response to these requests informally, you may contact the Access to Information and Privacy Division.

DIN
Drug Identification Number
MHPD
Marketed Health Products Directorate
NHP
Natural Health Product
NHPD
Natural Health Products Directorate
NPN
Natural Product Number
NOC
Notice of Compliance

Completed Requests

For the month of September 2010
Request # Request text
A-2007-00876 Copies of contracts, including any contract amendments, for the production of cannabis between Health Canada and Prairie Plant Systems Inc. (PPS), and any documents associated with the Request for Proposal during the period June 2007 to present (January 29, 2008).
A-2008-00003 All records generated by the discussion of smart regulations and the precautionary principle. The records for the last 12-month time period (April 1, 2007 to April 1, 2008) should include, but not be limited to, email correspondence between officials in Health Canada and other departments such as the Privy Council Office and Justice, briefing notes and reports.
A-2008-00181 All records, studying and documenting the impact that amendments to the Food and Drugs Act proposed under Bill C-51 would have on the natural health products industry and naturopaths (Documents from February 1, 2006 to present (May 27, 2008)).
A-2008-00855 Records related to a 2007 study conducted by Health Canada's Product Safety Laboratory that examined 100 children's toy obtained across Canada for the presence of phthalate plasticizers. Specifically, any records (paper documents, e-mails or otherwise) that lists the 100 children's toys studied, the name of the toy brands, and which ones contained the phthalate plasticizers.
A-2008-00964 Copies of all Health Canada assessment reports, including bioequivalence and chemistry assessment reports, for all strength of the prescription pharmaceutical Apo-Benazepril, manufactured by Apotex Incorporated.
A-2008-00969 All clinical information regarding the New Drug Submission and Supplemental New Drug Submissions filed for Motilium (domperidone). This includes review documents, comprehensive summaries, Product Monograph and other submission-related correspondence. (Motilium 10 mg tablet, marketed by Janssen-Ortho Inc, was discontinued January 7, 2002. Copy of the Product Monograph when the product was discontinued).
A-2008-00971 All records (including email correspondence) about investigation of delay at Health Canada in response to safety concerns posed by a Simplicity bassinet (recalled on August 29, 2008), from date announcement of investigation (by Minister of Health) on October 29, 2008 to December 31, 3008.
A-2008-01002 All email correspondence at consumer product safety branch at headquarters (only Ottawa) about compliance issues at retail outlets known as dollar stores. From January 1, 2008 to December 31, 2008.
A-2008-01066 Any and all correspondence regarding the smoking cessation drug Champix, specifically as it relates to pulling it off the market, relabeling, complaints and advisories. Timeframe, since Champix was marketed in Canada to present (March 9, 2009). Correspondence includes:
  • Health Canada departmental letters, emails, interoffice memos and personal notes
  • Letters/emails to and from Pfizer / Pfizer Canada
  • Letters/emails to and from the U.S. Food and Drug Administration (FDA) about Champix / Chantix (drug name in the U.S.).
A-2009-00417 Contents of the following inactive file in storage for the Natural Health Products Directorate: HPFB-NHPD3-175 "NHP Regulatory Framework / Therapeutic Products Programme (TPP) Response to Advisory Panel Final Report".
A-2009-00430 Five briefing notes/documents concerning H1N1 to the Minister for the months of May and June 2009.
A-2009-00734 The Clinical Assessment Package (CAP) document for the drug Zometa (zoledronic acid), and:
  • Reviewer's Report for the New Drug Submission (NDS) (Notice of Compliance (NOC) issued August 21, 2000 under priority review).
  • Reviewer's Report for the Supplemental NDS (SNDS) (NOC August 7, 2002 under priority review).
  • Reviewer's Report for the SNDS (NOC issued February 4, 2003).
  • Reviewer's Report for the SNDS (NOC issued July 30, 2003).
A-2009-00903 Safety reports from GlaxoSmithKline related to the H1N1 influenza vaccine.
A-2009-00917 All records during the period from January 1, 2005 to the present (November 3, 2009). For information pertaining to tobacco advertising directed at consumers. Interested in any studies or other analyses of (a) the extent and/or impact, if any, of tobacco advertising pursuant to s. 22(2) of the Tobacco Act; (b) the extent and/or impact, if any, of tobacco advertising in free newspapers and/or free entertainment weeklies; (c) the extent that minors are being exposed to tobacco advertising despite the Tobacco Act restrictions on advertising and (d) policy options for amending the advertising restrictions.
A-2009-01013
  1. A copy of the submission information and or application leading to the granting of DIN / Administrative DIN 02039076 in April 2008 to Trans Research International Trust Ltd.
  2. All correspondence to and from Health Canada concerning the granting of DIN / Administrative DIN 02039076
A-2009-01072 Bioequivalence Study Design for Novo-Tamsulosin (DIN: 02281392; NOC Date: 2006-10-03)
Comprehensive Summary-Bioequivalence.
A-2009-01164 Safety Efficacy Data and Reports related to the approval of H1N1 Vaccine from March 1, 2009 to December 31, 2009.
A-2009-01197 Any additional information related to the following adverse event reports: 000329061, 00327568, 000327688, 000327504, 000327502, 000329147 and 000328569.
A-2009-01387 Caffeinated Energy Drinks and the proposed Abbreviated Labelling Standard for Caffeinated Energy Drinks, including but not limited to:

All adverse event information; causality assessment; severity; adverse event description; all details concerning suspected and/or concomitant health products/medications/physiologically-active substances, labelled strength, manufacturer, dosage, frequency, route, therapy dates or duration, indication, dechallenge/challenge information; adverse event outcome; relevant tests; pre-existing medical conditions and history; treatment; reporter information; patient information.
A-2009-01414 All documents, including reviewers' notes, NHPD Submission, labelling associated with the approval of Visible White Toothpaste, NPN 80007191, marketed by Colgate Palmolive Canada Inc.
A-2009-01420 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Licence Number: 80015782
Product Name: Kalms
Licence Holder: G.R. Lane Health Products Limited
A-2009-01428 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Licence Number: 80015472
Product Name: Chlorophylle Liquide, Le Naturiste, Liquid Chlorophyll
Licence Holder: Vitaminol Inc.
A-2009-01435 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Licence Number: 80002311
Product Name: Dong Quai
Licence Holder: New Kingdom Natural Products Inc.
A-2009-01443 Product Licence submission in its entirety including the product licence application form, label text, evidence summary report, references, safety summary report, animal tissue form(s), quality summary report and all the associated information request notices and response of:

Licence Number: 80006113
Product Name: Genestra Brands Amino Complex, Amino Complex
Licence Holder: Seroyal International Inc.
A-2010-00120 Regarding Johnson & Johnson Inc - Aveeno Eczema Skincare Moisturizing Cream:
  1. Cosmetic Notification Forms (CNF) and reviewer's comments relating to the information submitted.
  2. Copy of any Safety Information supplied for the ingredients / products.
  3. Supporting information in reference to the moisturizing claims specific to the 'eczema' condition.
  4. All Health Canada correspondence relating to the Cosmetic Notification form submitted by the company, that was conducted prior to the product notification and during the CNF, including notes on discussions on labelling and claims.
  5. Comments from the Health Canada on evaluation of product labelling.
A-2010-00124 Please provide all regulatory submissions and related correspondence, reviewer's notes and other related information for

Product Name: Aquafresh White & Shine and Aquafresh White & Shine Berry Fresh
NPN: 02240400
A-2010-00130 Please provide all regulatory submissions and related correspondence, reviewer's notes and other related information for

Product Name: Sensodyne Pronamel For Children
NPN: 80009222
A-2010-00131 Please provide all regulatory submissions and related correspondence, reviewer's notes and other related information for

Product Name: Aquafresh Kidzmint Toothpaste
NPN: 02243813
A-2010-00134 Please provide all regulatory submissions and related correspondence, reviewer's notes and other related information for

Product Name: Colgate Sensitive and Colgate Sensitive Enamel Protect
NPN: 80000133
A-2010-00138 Request the most current Product Monographs/Prescribing Information for the following products:

Adrucil by Pfizer Canada Inc. (DIN 02063921)
Adrucil by Adria Laboratories of Canada Ltd. (DIN 00428493)
A-2010-00169 Non-confidential parts of Device Licence applications for two medical devices as follows: Wieland Zeno Zr Disc application, licence #71199. Procera Bridge [2] and Implant Bridge Zirconia (Nobel Biocare), licence 65132 and 70001. More specifically we would like to view the approved indications for use for the devices. In addition, we would like to view any public information that summarizes the safety and effectiveness data of these two devices.
A-2010-00204 Copies of the Quality Overall Summary (QOS) or Comprehensive Summary of the Chemistry and Manufacturing Information (CS(CM)) for the following products:

Sandostatin LAR (octreotide acetate) NOC dated 1998-12-23. DIN 02239323, DIN 02239324 and DIN 02239325.

Sandostatin (octreotide acetate) NOC dated 1997-08-18. DIN 00839191, DIN 00839205, DIN 02049392 and DIN 00839213.
A-2010-00229 Original adverse event reports by a health professional /layperson received by MHPD for:

ASPIRIN. Report numbers 000336049, 000336706, 000337843, 000337951 and 000338513.
A-2010-00230 Original adverse event reports by a health professional /layperson received by MHPD for:

ASPIRIN. Report number 000339192.
A-2010-00288 Serious adverse events reported with CELEXA - Adverse Event Report number 000332302.
A-2010-00336 Copies of the Clinical Reviewer's notes and Label reviewer's notes, and correspondence with the sponsor for the original New Drug Submission for the following drug product: TRI-CYCLEN LO (DINs 02258560 and 02258587).
A-2010-00377 Original submission forms used in reporting the following Adverse Event Reports to MHPD:

Product: THALOMID
Report number 000338613
A-2010-00382 Documents regarding NPN 80005012 (Traumeel S Ampoule, licensed to Heel Canada)
  • A list of references provided by the applicant in support of the recommended ('Homeopathic preparation used to relieve pain, inflammation and bruising'). This list appears in the Product License Application (PLA). An excerpt from the PLA, providing this information is what is requested.
  • Safety and Efficacy Assessment Report (SEAR), including all reviewer and Assessment officer comments, as they pertain to safety and efficacy

The material requested is the argumentation presented by the applicant, in substantiating the recommended use (Homeopathic preparation used to relieve pain, inflammation and bruising.
A-2010-00400 Documentation relating to the reclassification and/or staffing of the Dental Analysis and Support Clerk CR 04 positions to the anticipated CR 05 positions. Including drafts and final copies of the point rating, duties, and selection process and assessment methods.

CR 04 Position numbers:
  • RPMFB-1072
  • RPMFB-1216
  • RPMFB-1456
  • RPMFB-1574
  • RPMFB-01294
CR 05 Position numbers:
  • RPMFB-1539
  • RPMFB-1710
  • RPMFB-1711
  • RPMFB-1712
  • RPMFB-1713
  • RPMFB-1714
A-2010-00422 All communications between any Health Canada (HC) representative and any Canada Revenue Agency (CRA) representative between January 1998 to November 2002 pertaining to any Occupational Health and Safety investigations, reports of the workplace at 875 Heron Road.
A-2010-00434 Copies of the Standard Operating Procedures (SOPs) or Templates used by the evaluators of the sections (Cardiovascular Devices, General and Restorative Devices, In Vitro Diagnostic Devices, and Musculoskeletal Devices) of the Device Evaluation Division in the review of Licence Applications for Medical Devices.
A-2010-00445 Following information for Probaclac M (Owner: Les Laboratoires Nicar Inc.) NPN# 80013800:
  • Final approved label copy.
  • All reviews relating to product licence application.
  • Certificate of Analysis for all raw material and finished product used.
  • List of ingredients in the formulation - active and non-active.
  • All support documents to support claims.
  • Final approved copy of the product licence application.
A-2010-00464 Original adverse event reports by a health professional /layperson received by MHPD for:

BETASERON. Report number 000342241.
A-2010-00474 Any type of agreement made between the Health Canada Library and the National Research Council of Canada - Canada Institute for Scientific and Technical Information for the provision of serial, periodicals and journal management and acquisitions.
A-2010-00482 Original adverse event reports by a health professional /layperson received by MHPD for:

NEXAVAR. Report number 000340956.
A-2010-00513 Following information for C1000 TABLETS (Owner: JAMIESON) NPN# 00341207:
  • Final approved label copy.
  • All reviews relating to product licence application.
  • Certificate of Analysis for all raw material and finished product used.
  • List of ingredients in the formulation - active and non-active.
  • All support documents to support claims.
  • Final approved copy of the product licence application.
A-2010-00521 Copies of any agreements between the First Nations Health Society and Health Canada in the British Columbia Region. Time frame from January 1, 2008 until present (July 27, 2010).
A-2010-00563 Number (broken by the year) of:
  1. Adverse incidents related to the operation of Magnetic Resonance Imaging (MRI) equipment and/or
  2. adverse incidents involving cryogenic gases used in MRI equipment
  • dated between 1990- August 4, 2010
  • in the province of Ontario and Canada
A-2010-00587 All regulatory submission related correspondence, all clinical data, all chemistry data, reviewer's notes and any other related information as it pertains to the approved strengths of:

Product Name: GEN-ETIDRONATE Tablets 200mg
DIN: 02245330
Manufacture's Name: Genpharm Ulc
A-2010-00591 Original adverse event reports by a health professional /layperson received by MHPD for:

CIPRO XL. Report number 000343643.
A-2010-00592 Original adverse event reports by a health professional /layperson received by MHPD for:

CIPRO. Report number 000342682.
A-2010-00593 Original adverse event reports by a health professional /layperson received by MHPD for:

MIRENA. Report numbers 000342810, 000342830, 000342834, 000342893 and 000342915.
A-2010-00594 Original adverse event reports by a health professional /layperson received by MHPD for:

YASMIN. Report numbers 000342681 and 000343506.
A-2010-00597 Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) by Eisai Inc. From August 7 - 13, 2010.
A-2010-00605 Complete Departmental Casual Employee Appointment List, within the National Capital Region, effective April 1, 2010 up to and including August 1, 2010.
A-2010-00606 All temporary help call up's effective April 1, 2010 up to and including July 1, 2010.
A-2010-00610 The number of non-insured Watson Lake health benefit claims for painkillers and tranquilizers recorded by Health Canada for the additional years from 2003/2004 through to 2009/2010(August 19, 2010).
A-2010-00624 Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) by Eisai Inc. From August 14 - 20, 2010.
A-2010-00628 Provide the number of Special Authorization Program (SAP) authorizations for Dacogen (decitabine) by Eisai Inc. From August 21 - 27, 2010.
A-2010-00647 Adverse Event Reports for suspected PANTOLOC (pantoprazole sodium). Report number 000341100.
A-2010-00666 Original adverse event reports by a health professional /layperson received by MHPD for:

MIRENA. Report numbers 000346000, 000346372 and 000346540.
A-2010-00672 All Callups processed by this institution in the National Capital Region under the terms of any standing offer and/or supply arrangement for Temporary Help Services during the period: August 2010