Review decisions

Showing 60 results of 2190 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714574957940
Product Type: Drug
Control Number: 251688
DIN(s): 02542706
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-04-19
Decision / Authorization Date: 2023-11-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705588381487
Product Type: Drug
Control Number: 272785
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-02-27
Decision / Authorization Date: 2023-12-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705591073125
Product Type: Drug
Control Number: 269097
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-10-27
Decision / Authorization Date: 2023-12-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1709225685625
Product Type: Drug
Control Number: 271750
DIN(s): 02517140, 02526670, 02542277, 02542285
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-01-26
Decision / Authorization Date: 2023-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710785654782
Product Type: Drug
Control Number: 262030
DIN(s): 02543842, 02543850
Manufacturer: Emergent BioDefense Operations Lansing LLC
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-03-08
Decision / Authorization Date: 2023-12-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713896533366
Product Type: Drug
Control Number: 267923
DIN(s): 02542420
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-31
Decision / Authorization Date: 2023-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1703188857510
Product Type: Drug
Control Number: 264439
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-20
Decision / Authorization Date: 2023-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704984251239
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
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706285264505
Product Type: Drug
Control Number: 270386
DIN(s): 02409623, 02409658, 02539993
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-24