Review decisions

Showing 180 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758805441754
Product Type: Drug
Control Number: 275599
Manufacturer: Tersera Therapeutics LLC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2024-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742236852652
Product Type: Drug
Control Number: 264181
DIN(s): 02534169
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-12
Decision / Authorization Date: 2022-12-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742237812211
Product Type: Drug
Control Number: 263051
DIN(s): 02532964
Manufacturer: Novo Nordisk Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-06
Decision / Authorization Date: 2022-11-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742224350438
Product Type: Drug
Control Number: 285129
Manufacturer: Ferring Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-20
Decision / Authorization Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760716153939
Product Type: Drug
Control Number: 271059
DIN(s): 02423898, 02470608, 02480786
Manufacturer: Pfizer Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-29
Decision / Authorization Date: 2024-04-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741809569789
Product Type: Drug
Control Number: 285427
DIN(s): 02545004, 02554798
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2025-03-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742997691925
Product Type: Drug
Control Number: 274453
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-17
Decision / Authorization Date: 2025-02-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747919450929
Product Type: Drug
Control Number: 266917
DIN(s): 02420864, 02420872, 02445018, 02445026, 02554569, 02554577
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-08-11
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741871370149
Product Type: Drug
Control Number: 281754
DIN(s): 02555441
Manufacturer: Hikma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-04
Decision / Authorization Date: 2025-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1739369525149
Product Type: Drug
Control Number: 280386
DIN(s): 02552507
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-26
Decision / Authorization Date: 2024-10-10