Review decisions
Showing 280 results of 2270 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1698846935419
Product Type: Drug
Control Number: 271030
DIN(s): 02539888
Manufacturer: Mirum Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-12-28
Issued / Original Publication Date: 2023-10-27
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1724254451412
Product Type: Drug
Control Number: 271038
DIN(s): 02544903
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-28
Issued / Original Publication Date: 2024-08-21
Decision / Authorization Date: 2024-08-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00619
Product Type: Drug
Control Number: 253502
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-12-23
Updated Date: 2022-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00616
Product Type: Drug
Control Number: 254495
DIN(s): 02528908
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-12-20
Updated Date: 2022-12-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01051
Product Type: Drug
Control Number: 263500
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-19
Decision / Authorization Date: 2022-12-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01048
Product Type: Drug
Control Number: 260018
DIN(s): 02533472, 02533480
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-31
Decision / Authorization Date: 2022-12-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01058
Product Type: Drug
Control Number: 262060
DIN(s): 02533448, 02533456
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-04
Decision / Authorization Date: 2022-12-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01030
Product Type: Drug
Control Number: 268826
DIN(s): 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: 2022-10-18
Decision / Authorization Date: 2022-12-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01046
Product Type: Drug
Control Number: 263432
DIN(s): 02533294
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-04-19
Decision / Authorization Date: 2022-12-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01049
Product Type: Drug
Control Number: 259880
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-12-31
Decision / Authorization Date: 2022-12-08