Review decisions

Showing 120 results of 2299 total
Regulatory Decision Summary for Myalepta
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
Summary Safety Review - Colistin (colistimethate sodium) - Assessing the Potential Risk of Pseudo-Bartter Syndrome
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
Summary of Cancellation for Spikevax Bivalent (Original/Omicron BA.4/5)
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
Summary of Cancellation for Nuvaxovid
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
Summary Basis of Decision for Voranigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733494552846
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Issued / Original Publication Date: 2024-12-05
Decision / Authorization Date: 2024-08-27
Regulatory Decision Summary for Uplizna
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
Regulatory Decision Summary for Yervoy
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
Regulatory Decision Summary for Kalydeco
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
Regulatory Decision Summary for Doptelet
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
Regulatory Decision Summary for Noyada
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

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