Review decisions

Showing 1090 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00731
Product Type: Drug
Control Number: 229124
DIN(s): 02502380, 02502399, 02502402
Manufacturer: BGP Pharma ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-08-12
Decision / Authorization Date: 2020-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00841
Product Type: Drug
Control Number: 232047
DIN(s): 02508486, 02508494, 02508508, 02508516, 02508524, 02508532, 02508540, 02508559, 02508567, 02508575, 02508583, 02508591
Manufacturer: Ibsa Institut Biochimique SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-27
Decision / Authorization Date: 2020-11-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00572
Product Type: Drug
Control Number: 246729
DIN(s): 02521679, 02521687
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-11-24
Issued / Original Publication Date: 2022-01-31
Decision / Authorization Date: 2021-10-26
Updated Date: 2025-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00719
Product Type: Drug
Control Number: 244947
DIN(s): 02508176
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2020-10-12
Decision / Authorization Date: 2020-11-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00723
Product Type: Drug
Control Number: 234257
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: Supplement to an Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2019-12-11
Decision / Authorization Date: 2020-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00724
Product Type: Drug
Control Number: 233708
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-11
Decision / Authorization Date: 2020-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00750
Product Type: Drug
Control Number: 232078
DIN(s): 02508052, 02508060
Manufacturer: Rigel Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-09-30
Decision / Authorization Date: 2020-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00801
Product Type: Drug
Control Number: 233331
DIN(s): 02507838, 02507846
Manufacturer: HLS Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-11-19
Decision / Authorization Date: 2020-11-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00722
Product Type: Drug
Control Number: 234228
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-06
Decision / Authorization Date: 2020-11-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00732
Product Type: Drug
Control Number: 234407
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-12-12
Decision / Authorization Date: 2020-11-17