Review decisions
Showing 210 results of 2295 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1700495075939
Product Type: Drug
Control Number: 276302
DIN(s): 02541823, 02541831, 02541858, 02541866, 02552035, 02552078
Manufacturer: BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Issued / Original Publication Date: 2023-11-22
Decision / Authorization Date: 2023-09-28
Updated Date: 2024-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1688667089344
Product Type: Drug
Control Number: 262080
DIN(s): 02537818
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-04-08
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1689169951770
Product Type: Drug
Control Number: 265088
DIN(s): 02525755
Manufacturer: Alnylam Netherlands B.v.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-09
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687460395389
Product Type: Drug
Control Number: 266464
DIN(s): 02538539
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-29
Decision / Authorization Date: 2023-06-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1688659210251
Product Type: Drug
Control Number: 274152
DIN(s): 02531461, 02533197
Manufacturer: Pfizer Canada ULC, on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-04-06
Decision / Authorization Date: 2023-07-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687527077098
Product Type: Drug
Control Number: 264582
DIN(s): 02423898, 02470608, 02480786
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-26
Decision / Authorization Date: 2023-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1686747902362
Product Type: Drug
Control Number: 266313
DIN(s): 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-08-02
Decision / Authorization Date: 2023-06-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1685124881584
DIN(s): 02322285
Issued / Original Publication Date: 2023-06-07
Updated Date: 2023-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1728318721334
Product Type: Drug
Control Number: 275853
DIN(s): 02544156
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-06-01
Issued / Original Publication Date: 2024-10-06
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1685545138786
Product Type: Drug
Control Number: 264995
DIN(s): 02538164
Manufacturer: Emergent Travel Health Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-08
Decision / Authorization Date: 2023-05-18