Review decisions
Showing 150 results of 2299 total
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/RDS1699385708073
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2023-10-23
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/SSR1697629380576
DIN(s): 02404508, 02420201, 02493586, 02493594, 02494809, 02494817, 02495341, 02495368, 02497026, 02497034, 02502690, 02502704, 02505762, 02505770, 02513781, 02513803, 02515563, 02515571, 02516047, 02516055, 02540746, 02540754
Issued / Original Publication Date: 2023-10-27
Updated Date: 2023-10-27
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/RDS1697811489202
Product Type: Drug
Control Number: 268288
DIN(s): 02542250
Manufacturer: Teva Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-04
Decision / Authorization Date: 2023-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699032842238
Product Type: Drug
Control Number: 271331
DIN(s): 02542293, 02542307
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-01-12
Decision / Authorization Date: 2023-10-13
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/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