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Biosimilar biologic drugs in Canada: Fact Sheet (PDF Version - 126 K) A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale. Health Canada authorizes biosimilars for sale using the same rigorous regulatory standards for…

Notice: Update to Clinical Trial Site Information Form November 29, 2019 Our file number: 19-121907-606 In an effort to improve efficiencies, and to support the submission of Clinical Trial Applications (CTAs) using the electronic Common Technical Document (eCTD) format, Health…

Final Record of Decisions November 8, 2018 Meeting: Canada’s Medical Technology Companies (MEDEC) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario November 8,…

Final Record of Decisions May 24, 2018 Meeting: Canada’s Medical Technology Companies (MEDEC) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario May 24, 2018 (1:00…

Final Record of Decisions November 13, 2018 Meeting: Innovative Medicines Canada (IMC) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario November 13, 2018 (1:00…

Final Record of Decisions May 10, 2018 Meeting: Innovative Medicines Canada (IMC) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario May 10, 2018 (1:00 p.m. to 3:40…

Final Record of Decisions October 2, 2018 Meeting: Groupement provincial de l’industrie du médicament (GPIM) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program Holland Cross, 1600 Scott Street, Tower B Room 2048, Ottawa, Ontario October 2, 2018 (1:00…

Final Record of Decisions December 4, 2018 Meeting: Canadian Generic Pharmaceutical Association (CGPA) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 5th Floor, Boardroom 2048, Ottawa, Ontario December…

Final Record of Decisions June 5, 2018 Meeting: Canadian Generic Pharmaceutical Association (CGPA) Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program 1600 Scott Street, Holland Cross, Tower B, 5th Floor, Boardroom 2048, Ottawa, Ontario June 5, 2018…

Rozlytrek - Notice of Compliance with Conditions - Qualifying Notice Therapeutic Product Directorate Holland Cross, Tower "B" 6th Floor, 1600 Scott Street Address Locator #3106B OTTAWA, Ontario K1A 0K9 Dossier ID: E221250 Dear [Employee name removed] Hoffmann-La Roche Limited…

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