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Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply): Notice Date published: November 27, 2020 The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was made on November 27, 2020. This interim order (IO) introduces new measures to help…

Notice: Prescription Drug List (PDL): Multiple Additions Date: December 21, 2020 Our file number: 20-117402-338 The purpose of this Notice of Amendment is to notify about the additions of fostamatinib, givosiran, lemborexant, luspatercept, ozanimod, trientine, and voretigene…

Notice to stakeholders: Harmonizing fludeoxyglucose (F-18 FDG) product monographs Health Canada recommends modified wording for the indications and clinical uses of fludeoxyglucose (F-18 FDG) products in their product monographs. The modified wording aims to bring the indications…

Qualifying Notice - Verity - BCG Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa, Ontario K1A 0K9 Dossier ID: HC6-024-e215162 Control #: 221579 [employee's name removed] [employee's title removed] Verity…

Scientific Advisory Committee on Health Products for Women (SAC-HPW): Agenda Date and Time: February 23, 2021- 11:00 am-5:00 pm, EST Location: Virtual Chairperson: Lorraine Greaves (Chair), Louise Pilote (Vice-chair) Secretariat: Jenna Griffiths, Olufunmilola (Funmi) Adedeji,…

Notice: Prescription Drug List (PDL): Vitamin D February 22, 2021 Our file number: 21-103221-458 The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing of Vitamin D on the Prescription Drug List (PDL) to allow non-prescription status for…

Qualifying Notice - Opdivo Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa, Ontario K1A 0K9 Dossier ID: HC6-024-e177442 Control #: 239474 [employee's name removed] [employee's title removed] Bristol-Myers…

Consultation: Electronic media in prescription drug labelling draft guidance document From Health Canada Current status: Closed This consultation ran from March 12, 2021 to May 7, 2021. Comments were requested on the draft guidance . Who was the focus of this consultation Health…

Qualifying Notice - Keytruda Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa, Ontario K1A 0K9 Dossier ID: HC6-024-E171468 Control #: 239505 [employee's name removed] [employee's title removed] Merck…

Guidance for completing the Drug Submission Application Form Updated: March 31, 2021 Guidance For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. For all other submission types, only a…