Review decisions
Showing 20 results of 1317 total
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
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/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/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