Review decisions

Showing 10 results of 56 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722614231303
Product Type: Drug
Control Number: 277017
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-07-07
Decision / Authorization Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721416399864
Product Type: Drug
Control Number: 263226
DIN(s): 02547732
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-08
Decision / Authorization Date: 2024-05-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725974335075
Product Type: Drug
Control Number: 282009
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-13
Decision / Authorization Date: 2024-07-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722532649097
Product Type: Drug
Control Number: 281914
DIN(s): 02549891
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-12-08
Decision / Authorization Date: 2024-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1720539616626
Product Type: Drug
Control Number: 282374
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719926004455
Product Type: Drug
Control Number: 275762
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Decision / Authorization Date: 2024-06-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719422939290
Product Type: Drug
Control Number: 276501
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2024-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719934782015
Product Type: Drug
Control Number: 272660
DIN(s): 02549123, 02549131
Manufacturer: Eli Lilly Canada, Inc.
Submission Type: New Drug Submission (New Active Submission)
Date Filed / Submission Date: 2022-02-22
Decision / Authorization Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719321468799
Product Type: Drug
Control Number: 276884
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-06-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722440238663
Product Type: Drug
Control Number: 249557
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-02-16
Decision / Authorization Date: 2022-01-12