Review decisions

Showing 100 results of 2322 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1761838293179
Product Type: Drug
Control Number: 291800
DIN(s): 02481766, 02481774, 02481782, 02481790
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-10-30
Decision / Authorization Date: 2025-10-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762452482525
Product Type: Drug
Control Number: 250022
DIN(s): 02388006, 02388014, 02388022, 02434814
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-03-01
Decision / Authorization Date: 2022-05-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762446446110
Product Type: Drug
Control Number: 254599
DIN(s): 02530767, 02530775, 02530783, 02530791, 02530805, 02530813, 02530848, 02530856
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-23
Decision / Authorization Date: 2022-09-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762530020161
Product Type: Drug
Control Number: 257143
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-10-01
Decision / Authorization Date: 2022-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763397220652
Product Type: Drug
Control Number: 283028
DIN(s): 02562022, 02562030, 02562049, 02562057, 02562065
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-03-08
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764190417260
Product Type: Drug
Control Number: 286948
DIN(s): 02560720
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763654936354
Product Type: Drug
Control Number: 283307
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-31
Decision / Authorization Date: 2024-08-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762454184425
Product Type: Drug
Control Number: 249957
DIN(s): 02527073
Manufacturer: Dr. Reddy’s Laboratoties Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-02-26
Decision / Authorization Date: 2022-05-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760644087054
Product Type: Drug
Control Number: 289379
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-07
Decision / Authorization Date: 2025-07-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760638567382
Product Type: Drug
Control Number: 292883
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-12-02
Decision / Authorization Date: 2025-07-17