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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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Notice: Multiple additions to the Prescription Drug List (PDL) [2025-04-29] April 29, 2025 Our file number: 25-102881-952 The purpose of this Notice of Amendment is to notify about the addition of efanesoctocog alfa, fecal microbiota (human), inavolisib, loncastuximab tesirine,…

Publication of the guidance on data protection under C.08.004.1 of the Food and Drug Regulations: Notice June 16, 2025 Our reference number: 25-101572-962 Health Canada is pleased to announce an update to the Guidance Document: Data Protection under C.08.004.1 of the Food and…

Qualifying notice for Iqirvo (287772) - Canada.ca

Health CanadaCaptures 9Latest capture Apr 11, 2026en

Qualifying notice for Iqirvo (287772) Pharmaceutical Drugs Directorate Holland Cross, Tower "B" 6th Floor, 1600 Scott Street Address Locator 3106B Ottawa ON K1A 0K9 Dossier ID: e276996 Control number: 287772 [name of employee removed] Associate Director, Regulatory Affairs Ipsen…

New filing requirements for second language product monographs and package insert mock-ups: Notice June 20, 2025 Our file number: 25-101629-22 On March 10, 2023, Health Canada changed the submission requirements for second language product monographs (PM) for human drugs.…

Guidance document on submission information for biologic drugs (Division 4, Schedule D): Overview Overview Requirements – Division 4 Requirements – Other References, contacts Comparison of Division 4 – Former and new Download in PDF format (697 KB, 39 pages) Organization: Health…

Notice: Multiple additions to the Prescription Drug List (PDL) [2025-06-24] June 24, 2025 Our file number: 25-104183-77 The purpose of this Notice of Amendment is to notify about the addition of cipaglucosidase alfa, delafloxacin, elafibranor, lazertinib, omaveloxolone,…

Qualifying notice for Tagrisso (288417) - Canada.ca

Health CanadaCaptures 9Latest capture Apr 11, 2026en

Qualifying notice for Tagrisso (288417) Pharmaceutical Drugs Directorate Holland Cross, Tower "B" 6th Floor, 1600 Scott Street Address Locator 3106B Ottawa ON K1A 0K9 Dossier ID: e182735 Control number: 288417 AstraZeneca Canada Inc c/o [name of employee removed] Regulatory…

Notice to stakeholders – Implementation of ICH M13A: Bioequivalence for immediate release solid oral dosage forms December 27, 2025 Our file number: 25-102237-854 Background The International Council for Harmonisation (ICH)'s guideline entitled, ICH M13A: Bioequivalence for…

Notice: Revisions to the Drug Product Database’s terminology page July 4, 2025 Our file number: 25-104560 - 225 Health Canada is pleased to announce revisions to the Drug Product Database's (DPD) Terminology Page . This page provides end users of the Drug Product Database (DPD)…

Qualifying notice for Zynlonta (284436) - Canada.ca

Health CanadaCaptures 9Latest capture Apr 11, 2026en

Qualifying notice for Zynlonta (284436) Biologic and Radiopharmaceutical Drugs Directorate 100 Eglantine Driveway LCDC Building Tunney’s Pasture, A.L. 0601C Ottawa ON K1A 0K9 Dossier ID: e277127 Control number: 284436 Swedish Orphan Biovitrum AB (Publ) c/o [employee name removed]…

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