Review decisions
Showing 30 results of 1324 total
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721931544640
Product Type: Drug
Control Number: 254159
DIN(s): 02462990, 02492393
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-25
Decision / Authorization Date: 2022-03-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722952436074
Product Type: Drug
Control Number: 278042
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-08
Decision / Authorization Date: 2024-07-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723644947965
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-12
Decision / Authorization Date: 2024-02-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722962428155
Product Type: Drug
Control Number: 273487
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-20
Decision / Authorization Date: 2024-03-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722614231303
Product Type: Drug
Control Number: 277017
DIN(s): 02535270
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-07-07
Decision / Authorization Date: 2024-07-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721416399864
Product Type: Drug
Control Number: 263226
DIN(s): 02547732
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-08
Decision / Authorization Date: 2024-05-15