Review decisions

Showing 770 results of 2627 total
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00944
Product Type: Drug
Control Number: 257236
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-01
Decision / Authorization Date: 2022-04-07
Regulatory Decision Summary for Gardasil 9
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00938
Product Type: Drug
Control Number: 251509
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-04-07
Decision / Authorization Date: 2022-04-06
Regulatory Decision Summary for Jardiance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01039
Product Type: Drug
Control Number: 256491
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-09-09
Decision / Authorization Date: 2022-04-06
Summary Basis of Decision for Ixifi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00583
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-04-06
Summary Safety Review - Breast Implants - Assessing the Potential Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00283
Issued / Original Publication Date: 2022-04-06
Summary Basis of Decision for Sunlenca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00627
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-06
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-02
Updated Date: 2025-06-27
Regulatory Decision Summary for CHADOX1-S [RECOMBINANT] (VAXZEVRIA)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00943
Product Type: Drug
Control Number: 259446
DIN(s): 02510847
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-12-10
Decision / Authorization Date: 2022-03-31
Summary Basis of Decision for Armlupeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734963810994
Product Type: Drug
Control Number: 262990
DIN(s): 02550857
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Issued / Original Publication Date: 2024-12-22
Decision / Authorization Date: 2024-08-16
Regulatory Decision Summary for Palynziq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00937
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-14
Decision / Authorization Date: 2022-03-30
Regulatory Decision Summary for Rybrevant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00941
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2022-03-30

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