Review decisions

Showing 30 results of 633 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765205479281
Product Type: Drug
Control Number: 290364
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-23
Decision / Authorization Date: 2025-08-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768236073374
Product Type: Drug
Control Number: 280995
DIN(s): 00297763, 02555093
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-10
Decision / Authorization Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774965255993
Product Type: Drug
Control Number: 290817
DIN(s): 02454130, 02519011, 02519038, 02561514
Manufacturer: Aralez Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-10-01
Decision / Authorization Date: 2025-10-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765391179751
Product Type: Drug
Control Number: 298213
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-20
Decision / Authorization Date: 2025-12-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764967113004
Product Type: Drug
Control Number: 279915
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: 2023-10-13
Decision / Authorization Date: 2024-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773947348229
Product Type: Drug
Control Number: 282456
DIN(s): 02415690, 02561069
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-29
Decision / Authorization Date: 2025-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1769701234858
Product Type: Drug
Control Number: 292450
DIN(s): 02483084, 02483092
Manufacturer: Indivior UK Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-18
Decision / Authorization Date: 2025-12-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773243638118
Product Type: Drug
Control Number: 292646
DIN(s): 02537532, 02552566, 02556146
Manufacturer: Arcutis Canada, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765901981864
Product Type: Drug
Control Number: 290251
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-09
Decision / Authorization Date: 2025-04-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762525671043
Product Type: Drug
Control Number: 262828
DIN(s): 02323273
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-02-17