Review decisions
Showing 300 results of 2295 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01055
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-11-24
Decision / Authorization Date: 2023-01-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1722001162962
Product Type: Drug
Control Number: 271065
DIN(s): 02543931
Manufacturer: Horizon Therapeutics Ireland DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-12-30
Issued / Original Publication Date: 2024-07-24
Decision / Authorization Date: 2023-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01053
Product Type: Drug
Control Number: 241617
Manufacturer: ALK-Abello A/S
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-07-10
Decision / Authorization Date: 2022-12-29
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/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/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