Review decisions

Showing 10 results of 1274 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1720539616626
Product Type: Drug
Control Number: 282374
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719926004455
Product Type: Drug
Control Number: 275762
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Decision / Authorization Date: 2024-06-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719422939290
Product Type: Drug
Control Number: 276501
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2024-05-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719934782015
Product Type: Drug
Control Number: 272660
DIN(s): 02549123, 02549131
Manufacturer: Eli Lilly Canada, Inc.
Submission Type: New Drug Submission (New Active Submission)
Date Filed / Submission Date: 2022-02-22
Decision / Authorization Date: 2024-06-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719321468799
Product Type: Drug
Control Number: 276884
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-06-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719947956895
Product Type: Drug
Control Number: 254556
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-07-09
Decision / Authorization Date: 2022-02-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717432595126
Product Type: Drug
Control Number: 278277
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-08-15
Decision / Authorization Date: 2024-04-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717506584978
Product Type: Drug
Control Number: 269287
DIN(s): 02438070, 02547724
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-01
Decision / Authorization Date: 2024-05-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718733982360
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Decision / Authorization Date: 2024-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718716557847
Product Type: Drug
Control Number: 273103
DIN(s): 02243005
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-07
Decision / Authorization Date: 2024-02-20