Review decisions
Showing 580 results of 1550 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00943
Product Type: Drug
Control Number: 259446
DIN(s): 02510847
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2021-12-10
Decision / Authorization Date: 2022-03-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00937
Product Type: Drug
Control Number: 251687
DIN(s): 02526247, 02526255, 02526263
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-04-14
Decision / Authorization Date: 2022-03-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00941
Product Type: Drug
Control Number: 254440
DIN(s): 02526182
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-07-05
Decision / Authorization Date: 2022-03-30
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/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