Review decisions

Showing 50 results of 2190 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710259036712
Product Type: Drug
Control Number: 267148
DIN(s): 02541742
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-08-18
Decision / Authorization Date: 2023-09-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708632207803
Product Type: Drug
Control Number: 269016
DIN(s): 02248239, 02248240, 02248999, 02268892
Manufacturer: Tolmar International Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-25
Decision / Authorization Date: 2023-09-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706026709659
Product Type: Drug
Control Number: 273908
DIN(s): 02544555, 02544563, 02544571
Manufacturer: Amryt Pharmaceuticals DAC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1705515920269
DIN(s): 00476420, 02244849, 02403544
Issued / Original Publication Date: 2024-01-18
Updated Date: 2024-01-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705502911003
Product Type: Drug
Control Number: 274717
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-04-26
Decision / Authorization Date: 2023-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1705507252665
Product Type: Drug
Control Number: 273313
Manufacturer: Novavax Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2023-03-15
Decision / Authorization Date: 2023-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706812807082
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
Decision / Authorization Date: 2023-12-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706819201300
Product Type: Drug
Control Number: 270801
DIN(s): 02379384
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-12-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1713201445261
Product Type: Drug
Control Number: 273575
DIN(s): 02397412, 02442612, 02442620, 02519364, 02543451
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-03-24
Decision / Authorization Date: 2023-11-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714578062319
Product Type: Drug
Control Number: 248574
DIN(s): 02543907, 02543915
Manufacturer: Ethypharm Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-20
Decision / Authorization Date: 2023-12-18