- by Health CanadaA listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.
- by Health CanadaThis is a list of certain generic drug submissions currently under review. The Generic Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.
- by Health CanadaThis is a list of certain drug submissions currently under review. The Submissions Under Review list includes the medicinal ingredient(s) and therapeutic area.
- by Health CanadaThe Master File Application Form is used to provide Master file information to Health Canada. This form has been updated for Web Content Accessibility Guidelines compliance.
- by Health CanadaProduct Monograph Brand Safety Updates for Submissions cleared between 08-01-2023 and 08-31-2023
- by Health CanadaListing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection Regulations.
- by Health CanadaHealth Canada updated the 2020 Product monograph guidance and master template to provide more information and guidance for manufacturers when developing a product monograph and reduce the administrative burden for both industry and regulator when preparing and reviewing a product monograph for approval. We are seeking your feedback and comments on the proposed changes to the documents and we will use the information gathered from this consultation to finalize the updates to both documents.
- by Health CanadaThe data extract is a series of compressed ASCII text files of the Notice of Compliance (NOC) database.
- by Health CanadaA listing of drugs pursuant to sub-section C.08.004.1(9) of the Food and Drug Regulations.
- by Health CanadaHealth Canada Summary Basis of Decision 2023-08-30. Winlevi, clascoterone, 1% (w/w), cream, Sun Pharmaceutical Industries Limited. Submission Control Number 265619
- by Health CanadaHealth Canada Summary Basis of Decision 2023-08-04. Quviviq, daridorexant, 25 mg and 50 mg, tablet, Idorsia Pharmaceuticals Ltd. Submission Control Number 255507
- by Health CanadaHealth Canada Summary Basis of Decision 2023-07-20. Onakta, tirbanibulin, 1% w/w, ointment, Avir Pharma Inc. Submission Control Number 262080
- by Health CanadaHealth Canada Summary Basis of Decision 2023-07-07. Imcivree, setmelanotide, 10 mg/mL, solution, Rhythm Pharmaceuticals, Inc. Submission Control Number 263432
- by Health CanadaOn September 12, 2023, Health Canada authorized the Moderna Spikevax Monovalent COVID-19 vaccine for the Omicron XBB.1.5 variant. This vaccine is authorized for use in people 6 months and older regardless of their vaccination history. This means for those who have been previously vaccinated, and those who have not been previously vaccinated.
- by Health CanadaListing of drugs pursuant to sub-section 120(1) of the Certificate of Supplementary Protection Regulations.