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Notice: Multiple additions to the Prescription Drug List (PDL) December 22, 2022 Our file number: 22-113424-10 The purpose of this Notice of Amendment is to notify about the addition of finerenone, lenacapavir, mavacamten, selumetinib, ubrogepant to the Prescription Drug List…

Qualifying notice for Kymriah Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney’s Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-e204549 Control #: 263500 [Employee name removed] [Employee title removed] Novartis…

Notice of Amendment: Betaine removed from the Prescription Drug List (PDL) January 6, 2023 Our file number: 22-113665-91 The purpose of this Notice of Amendment is to announce that Health Canada has removed “Betaine or its salts” from the Veterinary part of the Prescription Drug…

Drug shortages in Canada: Information for consumers Overview Information for consumers Information for industry Regulations and guidance Information for health care providers Multi-stakeholder steering committee On this page Information on drug shortages What we're doing What you…

Qualifying notice amendment for Opdivo Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-e177442 Control #: 259148 [employee's name removed] [employee's title removed]…

Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies (PDF Version - 634 KB) Date Adopted: 2012/02/08 Revised Date: 2023/01/30 Effective Date: 2018/09/01 (for submissions filed on or after September 1, 2018) Please refer to the Notice to stakeholders –…

Qualifying notice for Opdivo Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney's Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: HC6-024-e177442 Control number: 253652 [employee title removed] Bristol-Myers Squibb Canada Co. 2344…

Qualifying notice for Ocaliva Dossier ID : e186967 [name of employee removed] [title of employee removed] Intercept Pharmaceuticals, Inc. 4760 Eastgate Mall San Diego, CA 92121 USA Dear [name of employee removed]: This Notice of Compliance with Conditions Qualifying Notice…

Consultation: Registration of Clinical Trials and Public Disclosure of Results: Draft Guidance and Public Search Portal From Health Canada Current status: Closed This consultation ran from February 23, 2023 to April 24, 2023. Health Canada has developed a draft guidance document…

Notice to stakeholders: Requests to the Special Access Program (SAP) involving psychedelic-assisted psychotherapy February 27, 2023 Our file number: 23-100122-763 On this page Purpose Background Process for making an SAP request Contact us Purpose Health Canada recognizes the…