Review decisions

Showing 10 results of 123 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729607296633
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729098917291
Product Type: Drug
Control Number: 281745
DIN(s): 02551012, 02551020, 02551039
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-01
Decision / Authorization Date: 2024-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1728568404321
Product Type: Drug
Control Number: 279827
DIN(s): 02527138
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-11
Decision / Authorization Date: 2024-09-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727378042656
Product Type: Drug
Control Number: 279552
DIN(s): 02505541, 02505568
Manufacturer: Celgene Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-09-29
Decision / Authorization Date: 2024-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727284854344
Product Type: Drug
Control Number: 278399
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-21
Decision / Authorization Date: 2024-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1726763640809
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Decision / Authorization Date: 2024-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977
Product Type: Drug
Control Number: 278712
DIN(s): 02550520, 02550539, 02550547
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-30
Decision / Authorization Date: 2024-08-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772
Product Type: Drug
Control Number: 277532
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-07-26
Decision / Authorization Date: 2024-08-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729525313633
Product Type: Drug
Control Number: 282415
DIN(s): 02243835, 02548968
Manufacturer: Sandoz Canada Incorporated
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28