Review decisions
Showing 10 results of 1308 total
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/RDS1727874290637
Product Type: Drug
Control Number: 283782
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-02-09
Decision / Authorization Date: 2024-09-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725633192834
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727446158111
Product Type: Drug
Control Number: 260666
DIN(s): 02550679
Manufacturer: Kye Pharmaceuticals
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-18
Decision / Authorization Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724779172737
Product Type: Drug
Control Number: 282981
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-19
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724850954021
Product Type: Drug
Control Number: 283003
Manufacturer: Seagen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-01-22
Decision / Authorization Date: 2024-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724332454521
Product Type: Drug
Control Number: 262990
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Decision / Authorization Date: 2024-08-16