Review decisions

Showing 220 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738869825385
Product Type: Drug
Control Number: 283004
DIN(s): 02450283
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-01-22
Decision / Authorization Date: 2024-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1761315404285
Product Type: Drug
Control Number: 294637
DIN(s): 02560771
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-01-28
Issued / Original Publication Date: 2025-10-23
Decision / Authorization Date: 2025-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766066698275
Product Type: Drug
Control Number: 294551
DIN(s): 02561492
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2025-01-27
Issued / Original Publication Date: 2025-12-17
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738608725112
Product Type: Drug
Control Number: 282097
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-14
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747926145388
Product Type: Drug
Control Number: 270381
DIN(s): 02409607, 02409615, 02540053
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1743436509830
Product Type: Drug
Control Number: 262779
DIN(s): 02473569
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-02-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1749230174238
Product Type: Drug
Control Number: 270609
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-13
Decision / Authorization Date: 2023-07-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738166485959
Product Type: Drug
Control Number: 282347
DIN(s): 02484552
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-21
Decision / Authorization Date: 2024-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1737471275836
Product Type: Drug
Control Number: 286426
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-29
Decision / Authorization Date: 2024-11-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1737562476931
Product Type: Drug
Control Number: 278522
DIN(s): 02324032, 02371081
Manufacturer: Merz Pharmaceuticals GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-24
Decision / Authorization Date: 2024-12-11