Review decisions

Showing 90 results of 2186 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697216175270
Product Type: Drug
Control Number: 243224
DIN(s): 02541602, 02541610, 02541629, 02541637
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-20
Decision / Authorization Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695846822831
Product Type: Drug
Control Number: 276302
Manufacturer: Pfizer Canada ULC (on behalf of BioNTech Manufacturing GmbH)
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694116967823
Product Type: Drug
Control Number: 275936
DIN(s): 02541270
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-06-29
Decision / Authorization Date: 2023-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696002316689
Product Type: Drug
Control Number: 268221
DIN(s): 02490064, 02490072, 02490080, 02490099, 02490102
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-09-27
Decision / Authorization Date: 2023-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1696430838362
Product Type: Drug
Control Number: 211762
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2017-02-13
Decision / Authorization Date: 2018-07-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698937127708
Product Type: Drug
Control Number: 243288
DIN(s): 02456214, 02456222
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2020-08-27
Decision / Authorization Date: 2021-01-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694525571508
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Decision / Authorization Date: 2023-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1707315192044
Product Type: Drug
Control Number: 278519
DIN(s): 02543656
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-09-01
Issued / Original Publication Date: 2024-02-09
Decision / Authorization Date: 2023-12-05
Updated Date: 2024-03-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1693487564948
Product Type: Drug
Control Number: 275559
DIN(s): 02541025
Manufacturer: Pfizer Canada ULC, on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2023-08-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1691692252806
DIN(s): 01912070, 02103613, 02236466, 02236857, 02238341, 02268078, 02350440, 02369206, 02403218, 02403870, 02408937, 02445034, 02462834
Issued / Original Publication Date: 2023-08-30
Updated Date: 2023-08-30