Since June, 2006 to present (May 22, 2008), provide Health Canada's comments/analyses, reports on two drug patent court decisions and on their potential effect on drug prices, namely the Supreme Court of Canada decision - AstraZeneca, 2006 FC 49, and the Federal Court of Appeal decision - Ratiopharm vs. Wyeth, 2007 FCA 264.

Include comments/submissions of drug company or trade association officials or their representatives or lobbyists communications exchanged with HC officials and the Minister office, the Minister, including notes of meetings held or prepared for meetings, including as part of regular meetings/communications on drug patent issues.

Include Health Canada's assessments of those meetings/exchanges, and media lines/communications plan developed separately from Industry Canada on these two Court decisions.

All documents of Apotex Incorporated submissions for the notices of compliance for the medicine nefazodone and/or nefazodone hydrochloride, including, without limitation:

1. Any Supplemental Abbreviated New Drug Submissions', notifiable changes, notices of change or other updates sent for nefazodone and/or nefazodone hydrochloride
2. All internal and external correspondence
3. Tracking documents
4. Acknowledgement letters
5. Reviewer's comments
6. Review of correspondence concerning chemistry and manufacturing and
7. With respect to any bulk suppliers of nefazodone and/or nefazodone hydrochloride, copies of any and all bi-annual update letters, and any and all documents filed whereby, the suppliers of bulk nefazodone and/or nefazodone hydrochloride indicate whether there has been change in the information contained in their drug master file

Info at the Therapeutic Products Directorate on BioMatrix Drug Eluting Stent (DES) manufactured by Biosensors Int'l.  The info Being requested includes:

1. Labelling (IFU)
2. clinical evidence to support safety and effectiveness
3. copies of Special Access Authorization Letters,
4. approval status of the drug Biolimus A9 (aka BA-9) and Notice of Compliance number
5. submission status of device license application for BioMatrix DES
6. submission date of licence application for this device, and
7. Executive Summary and Table of Contents of Licence Application Submission, if one has been filed

• - a copy of Health Canada's (HC) Intellectual Property (IP) Policy and any accompanying guidelines
• - the number of IP disclosures by HC scientific staff, by year, from 2000 to 2009
• - the number of licenses granted to non-government organizations, by year, from 2000-2009
• - the amount of annual revenue received from such licenses, by year, from 2000-2009
• - the annual expenditure for supporting the IP management/marketing activity, by year, from 200-2009
• - the number and amount of awards given to HC employees as a result of IP revenues received, by year, from 1999 to 2009
• - the percentage used to determine the amount of the annual award to HC inventors/innovators (i.e, between 15-35%)
• - the number of times, by year, that HC has given an IP award to an innovator rather than just to an inventor, between 2000 and 2009, as per the 1993 Treasury Board policy
• - who pays for the protection of any internally developed IP, the IP/business office or the originating laboratory
• - other than to the inventor/innovator, how is the remaining IP revenue dispersed
• - how many times, and when, HC has awarded an HC scientist/engineer with the IP award for government use of internally developed IP
• - any guidelines that assist HC contracting personnel in determining whether IP will be developed in a contract, and who is to own the IP
• - the number of times HC has invoked the Treasury Board exclusion clause to retain IP from a procurement contract, and what was the circumstances
• - a description of any training that has been provided to HC scientific/engineering staff to enable them to more effectively identify, protect, and mange IP developed during the course of the work
• - how frequently this training is provided, and who provided it
• - how many times staff from the HC IP business office have visited their laboratories, particularly Winnipeg, outside of Ottawa, per year, from 2000 to 2009

Information from Clinical Trials that GlaxoSmithKline (GSK) or the manufacturer of the time submitted to Health Canada. The clinical trials and both pre marketing and licensing and post marketing and licensing.  Information that caused alcohol abuse to have been noted as a side affect. The studies that pointed to this side affect and any and all references to alcohol abuse and this drug, and any other references to any other SSRI and Alcohol Abuse. Include discussions, investigations, placebo affects etc, that would have been communicated with GSK or the previous manufacturer and Health Canada from pre marketing to present.

Please refer to highlighted area on Paxil page 1193.  The quote is Alcohol the concomitant use of Paroxetine and Alcohol has not been studied and is not recommended. Patients should be advised to avoid alcohol while taking paroxetine. This seems to contradict the link to Alcohol abuse under the side affects of Paxil. It also contradicts a study done by Yale University in 1994. I am looking for any communications concerns these statements or any other concerning Alcohol and increased carvings for Alcohol.

Dollar amount and yearly change of discretionary operating expenses, including travel, office supplies, temporary labour etc: methods of payment used to settle such expenses; Acquisition, Travel and Fleet Cards number and dollar amount  spent, over time, total and by type of card and issuing bank; best practices using such cards; benefits from cards including savings achieved; user attitudes and barriers to adoption; card supplier selection criteria; copy of RFPs issued to card service cos; progress with recommendations of May 2007 OAGC Audit on such cards - please see http://www.oag-bvg.gc.ca/internet/English/parl_oag_200705_01_e_17476.html#ch1hd3b

The time period would at minimum be the latest 2 full years of information available, in order to establish a recent level and growth trend, with a historical reference point - say 2005.

1. The number of patients from Northwest Territories (NWT) who has received dental treatments under general anaesthesia (GA) per year from 2005-2006, 2006-2007, 2007-2008, 2008-2009 and 2009-2010.
2. The number of patients from each NWT Regions (Inuvik, Sahtu, Behcho, North Slave, South Slave) who has received dental treatments under GA per year for the past 5 years.
3. Annual medical spending for NWT patients receiving dental treatments under GA for the past 5 years.
4. Annual travel & related cost to send those patients to the service area where the dental treatment & GA is performed for the past 5 years.

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: 80002999
Product Name: Schuessler Tissue Salts Weak Nails Comb
Licence Holder: K - Martin & pleasance Ply Ltd

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: 80004370
Product Name: Immunocal, Hms-90
Licence Holder: Immunotec Inc

Details about the health device license application for the following:

Advanced Sterilization Products, a Division of Ethicon0
33 Technology Drive0
Irvine, CA, US 92618

Medical Device License 659640
Evotech integrated endoscope disinfection system

Information regarding the following:

Product Name: Aquafresh Extreme Clean Powerwhite Toothpaste
NPN: 02248618

All regulatory submissions and related correspondence, reviewer's notes and other related information as it pertains to the product listed above.

Information regarding the following:

Product Name: Colgate Simply White Toothpaste
NPN: 80001592

All regulatory submissions and related correspondence, reviewer's notes and other related information as it pertains to the product listed above.

All copies from the Therapeutic Products Directorate of Information relating to the approval of the following product manufactured by ACCUDIAL INC: Chest Congestion (DIN 02323796).

• - Documents related to the original submissions and any subsequent changes (including all additional submissions and any supporting data: Clarifaxes, telephone, and email request and responses; communications between Health Canada and the company; approved labels).
• - Reviewer's reports/notes for all submissions.

1. Provide the standard, the protocol and policy for a 'fitness to work evaluation' for the Statistics Canada Field Interviewers
2. Provide the forms that are required
3. Provide the policy to show if the employer makes the appointment or the employee makes the appointment
4. Show how the appointment is done and where
5. Give the forms for consent to me -- re consent to undergo fitness evaluation and consent to release medical information
6. Advise who in the Kelowna area is the doctor who does the evaluation
7. Provide the policy to show how health information flows from my health file to a) Health Canada and to b) the employer

Copies of the following records kept by Health Canada and the Natural Health Product Directorate (NHPD) concerning the following companies and brands, all of which are wholly-owned subsidiaries of Atrium Innovations Inc. (Atrium):

• - Type of information: adverse reaction reports filed with Health Canada/NHPD between 2004 and present concerning any products manufactured or marketed by each of the following companies or under their corresponding brands;
• - Company Name: Laboratories Mauves (now part of Atrium Innovations Inc.) 
• - Company Code (NPN Holder Number): 11510 (now under #11980)
• - Site Licence Number (if applicable): 300098
• - Brands and Trademarks: Mauves

Information from Health Canada for the drug product Androgel (testosterone gel):

1. A detailed copy of adverse drug reaction case #000335720 (initial and latest report received 2009-12-04). The abstract for this case was found in the Canada Vigilance Adverse Reaction Online Database. Any further details or subsequent reports regarding this case are also requested. The adverse reaction term(s) cited on the report are: drug ineffective, medication residue and product quality issue.
2. A detailed copy of adverse drug reaction case #000330916 (initial and latest report received 2009-10-06). The abstract for this case was found in the Canada Vigilance Adverse Reaction Online Database. Any further details or subsequent reports regarding this case are also requested. The adverse reaction term(s) cited on the report is: pulmonary embolism

information from Health Canada for the drug product Luvox (fluvoxamine maleate) tablets:

1. A detailed copy of adverse drug reaction case #000332049 (initial and latest report received 2009-10-27). The abstract for this case was found in the Canada Vigilance Adverse Reaction Online Database. Any further details or subsequent reports regarding this case are also requested. The adverse reaction term(s) cited on the report are: anaemia, brain injury, central nervous system lesion, contusion, convulsion, haematochezia, hypoaesthesia, hypoaesthesia facial, insomnia, oedema peripheral, paraesthesia, skin disorder, skin exfoliation, skin laceration, sleep study abnormal, swelling, swelling face, ulcer, weight decreased.

The most current product insert/prescribing information for the following:

Baciject 50,000 units/vial by Sterimax. (DIN 02245571)
Bacitracin USP by Pfizer Canada Inc. (DIN 00030708)

Drug reaction reports related for:

Ferring Case Number: 2010-CA-013
Canada Vigilance Number: 000336766

Per Quarter, the sales and the importations in Canada and exportations from Canada of: Cigar (In Sticks), Snuff (in Kilo), Chewing Tobacco (in Kilo), Pipe Tobacco (in Kilo), cigarette (In sticks), roll your own tobacco (in Kilo).

Starting quarter Q1 (calendar basis) 2000, Ending Quarter Q1 (calendar basis) 2010

Provide source documents (complete reports) for the cases below involving Multaq (dronedarone). These should include at a minimum the following information: reaction onset, therapy dates and outcome.

Report ID: 000339294, 000339627, 000337588, 000338245, 000338322, 000338324, 000343434, 000343636

Detailed reports for the following cases:

• -Canada Vigilance Database #000339211 (Product Testim; Non-serious; Adverse Reactions: Breast Pain, Breast Swelling and Hyperaesthesia).
• -Canada Vigilance Database #000334674 (Product Testim; Non-serious; Adverse Reactions: Skin odour abnormal).

Previously Released Info: A-2006-00125 Regarding Paxil.

A-2006-00125 reads as follows:
Request Health Canada documentation related to the anti-depressant medication Paxil (paroxetine; GlaxoSmithKline Inc, 10 mg, 20 mg and 30 mg). Specifically, The PSEAT (Pharmaceutical Safety and Efficacy Assessment Template). Where no PSEAT has been written or published, forward relevant safety and efficacy review summaries.