Review decisions

Showing 1180 results of 2632 total
Regulatory Decision Summary for Anthim
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00680
Product Type: Drug
Control Number: 230825
DIN(s): 02502895
Manufacturer: Elusys Therapeutics Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2019-08-16
Decision / Authorization Date: 2020-07-30
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00690
Product Type: Drug
Control Number: 231031
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-22
Decision / Authorization Date: 2020-07-29
Summary Basis of Decision for Dojolvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00527
Product Type: Drug
Control Number: 242196
DIN(s): 02512556
Manufacturer: Ultragenyx Pharmaceutical Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-07-28
Issued / Original Publication Date: 2021-05-03
Decision / Authorization Date: 2021-02-15
Updated Date: 2023-07-11
Regulatory Decision Summary for Veklury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00669
Product Type: Drug
Control Number: 240551
DIN(s): 02502135, 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Decision / Authorization Date: 2020-07-27
Summary Basis of Decision for Enhertu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00539
Product Type: Drug
Control Number: 242104
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-07-24
Issued / Original Publication Date: 2021-07-09
Decision / Authorization Date: 2021-04-15
Updated Date: 2025-05-30
Summary Safety Review - Methadone-Containing Products Used to Treat Opioid Dependence - Assessing the Potential Risk of Lack of Effect when Switching between Different Products
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00243
Issued / Original Publication Date: 2020-07-17
Regulatory Decision Summary for Fibryga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00678
Product Type: Drug
Control Number: 230407
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-06
Decision / Authorization Date: 2020-07-16
Regulatory Decision Summary for Tomvi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00694
Product Type: Drug
Control Number: 231245
DIN(s): 02498650
Manufacturer: Sterimax Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-08-30
Decision / Authorization Date: 2020-07-15
Regulatory Decision Summary for Xenleta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00767
Product Type: Drug
Control Number: 233292
DIN(s): 02501821, 02501848
Manufacturer: Sunovion Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-11-07
Decision / Authorization Date: 2020-07-10
Regulatory Decision Summary for Polivy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00713
Product Type: Drug
Control Number: 232303
DIN(s): 02499614
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-07
Decision / Authorization Date: 2020-07-09

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