Review decisions

Showing 780 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00940
Product Type: Drug
Control Number: 252306
DIN(s): 02526190
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-04-30
Decision / Authorization Date: 2022-03-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1687791867767
Product Type: Drug
Control Number: 262815
Manufacturer: Red Leaf Medical Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-25
Decision / Authorization Date: 2023-05-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00929
Product Type: Drug
Control Number: 259747
Manufacturer: Héma-Québec
Submission Type: Application for an Authorization Amendment
Date Filed / Submission Date: 2021-12-20
Decision / Authorization Date: 2022-03-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1704300260963
Product Type: Drug
Control Number: 262740
DIN(s): 02541009
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-24
Issued / Original Publication Date: 2024-01-03
Decision / Authorization Date: 2023-08-31
Updated Date: 2024-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00934
Product Type: Drug
Control Number: 253642
DIN(s): 02525178
Manufacturer: Taro Pharmaceuticals Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2021-06-16
Decision / Authorization Date: 2022-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00936
Product Type: Drug
Control Number: 256178
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-08-30
Decision / Authorization Date: 2022-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01057
Product Type: Drug
Control Number: 245791
DIN(s): 02526115
Manufacturer: Kadmon Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-11-03
Decision / Authorization Date: 2022-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01096
Product Type: Drug
Control Number: 255781
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2021-08-13
Decision / Authorization Date: 2022-03-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-23
Issued / Original Publication Date: 2024-11-07
Decision / Authorization Date: 2024-04-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1736172049201
Product Type: Drug
Control Number: 260666
DIN(s): 02550679
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-03-18
Issued / Original Publication Date: 2025-01-02
Decision / Authorization Date: 2024-08-21