Review decisions

Showing 170 results of 633 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702069947544
Product Type: Drug
Control Number: 268590
DIN(s): 02324032, 02371081
Manufacturer: Merz Pharmaceuticals GmbH / Merz Pharma Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-10-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1700599569568
Product Type: Drug
Control Number: 274515
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-19
Decision / Authorization Date: 2023-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698933880208
Product Type: Drug
Control Number: 268334
DIN(s): 02401347
Manufacturer: Seagen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699548065621
Product Type: Drug
Control Number: 269852
DIN(s): 02491559, 02533448, 02533456
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-17
Decision / Authorization Date: 2023-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723138153805
Product Type: Drug
Control Number: 280378
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-26
Decision / Authorization Date: 2024-05-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698157968254
Product Type: Drug
Control Number: 272451
DIN(s): 02542315, 02542323, 02542331, 02542358, 02542366
Manufacturer: Sandoz Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698845236805
Product Type: Drug
Control Number: 267554
DIN(s): 02495155, 02520893, 02539721
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-16
Decision / Authorization Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1715716170652
Product Type: Drug
Control Number: 268982
DIN(s): 02435462, 02435470
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-24
Decision / Authorization Date: 2023-10-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698782364007
Product Type: Drug
Control Number: 272553
DIN(s): 02469367, 02469375, 02469383, 02469405
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-20
Decision / Authorization Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698843751956
Product Type: Drug
Control Number: 266249
DIN(s): 02482592
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-07-20
Decision / Authorization Date: 2023-07-06