Review decisions

Showing 80 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764699279574
Product Type: Drug
Control Number: 276210
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-06-14
Decision / Authorization Date: 2024-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764349722993
Product Type: Drug
Control Number: 293030
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-12-03
Decision / Authorization Date: 2025-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764697588695
Product Type: Drug
Control Number: 286962
DIN(s): 02512963, 02554267
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-05-30
Decision / Authorization Date: 2024-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764348115107
Product Type: Drug
Control Number: 288031
DIN(s): 02244826, 02562804
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-06-25
Decision / Authorization Date: 2025-11-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1772572548469
Product Type: Drug
Control Number: 290784
DIN(s): 02561441
Manufacturer: Sterimax Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2025-01-03
Decision / Authorization Date: 2025-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763395478806
Product Type: Drug
Control Number: 290401
DIN(s): 02562510, 02562529
Manufacturer: Sandoz Canada Incorporated
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-11-15
Decision / Authorization Date: 2025-10-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763147717777
Product Type: Drug
Control Number: 284023
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541, 02552698
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-16
Decision / Authorization Date: 2025-04-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770215913714
Product Type: Drug
Control Number: 292379
DIN(s): 02541599, 02562634
Manufacturer: Argenx BV
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-15
Decision / Authorization Date: 2025-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765395299369
Product Type: Drug
Control Number: 287978
DIN(s): 02514931, 02560747
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-06-24
Decision / Authorization Date: 2025-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774984682517
Product Type: Drug
Control Number: 292164
DIN(s): 02552434
Manufacturer: Incyte Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-08
Decision / Authorization Date: 2025-10-09