Review decisions
Showing 210 results of 359 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/SBD1741785597925
Product Type: Drug
Control Number: 279310
DIN(s): 02552914
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-21
Issued / Original Publication Date: 2025-03-11
Decision / Authorization Date: 2024-11-06
Updated Date: 2025-08-01
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/SBD1741184642625
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Issued / Original Publication Date: 2025-03-05
Decision / Authorization Date: 2024-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734969149034
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Issued / Original Publication Date: 2024-12-19
Decision / Authorization Date: 2025-01-02
Updated Date: 2025-01-02
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/SBD1736956096867
Product Type: Drug
Control Number: 278913
DIN(s): 02551764, 02551772, 02551780, 02551799
Manufacturer: Blueprint Medicines Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-07
Issued / Original Publication Date: 2025-01-14
Decision / Authorization Date: 2024-09-18
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: 2025-03-21