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Health Canada RSS - Drug Products, Drugs and Health Products
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Last updated about 2 months ago
Guidance Document: Preparation of the XML Product Monograph (XML PM) [2025-03-31]
2 months ago
The purpose of this guidance document is to assist sponsors in developing...
Qualifying notice for Enhertu (285834)
3 months ago
A Notice of Compliance with Conditions (NOC/c) is authorization to market a...
Share your views: Consultation on draft guidance on co-packaged drug products
3 months ago
Consultation for draft guidance on co-packaged drugs.
What we heard: Draft guidance on expanded access clinical trials
4 months ago
This report provides background and context for the draft guidance, summarizes the...
Qualifying notice amendment for Lumakras (274523) [2025-01-29]
4 months ago
A Notice of Compliance with Conditions (NOC/c) is authorization to market a...
Summary Basis of Decision for Capvaxive
4 months ago
Health Canada Summary Basis of Decision 2024-12-16. Capvaxive, pneumococcal 21-valent conjugate vaccine...
Summary Basis of Decision for Fruzaqla
4 months ago
Health Canada Summary Basis of Decision 2025-01-02. Fruzaqla, fruquintinib, 1 mg and...
Summary Basis of Decision for Adheroza
4 months ago
Health Canada Summary Basis of Decision 2025-01-15. Adheroza, trastuzumab 150 mg/vial and...
Summary Basis of Decision for Armlupeg
4 months ago
Health Canada Summary Basis of Decision 2024-12-23. Armlupeg, pegfilgrastim, 6 mg/0.6 mL...
Summary Basis of Decision for Ebglyss
4 months ago
Health Canada Summary Basis of Decision 2024-12-18. Ebglyss, lebrikizumab, 250 mg/2 mL...
Summary Basis of Decision for Voranigo
4 months ago
Health Canada Summary Basis of Decision 2024-12-05. Voranigo, vorasidenib, 10 mg and...
Summary Basis of Decision for Ayvakyt
4 months ago
Health Canada Summary Basis of Decision 2025-01-14. Ayvakyt, avapritinib, 25 mg, 50...