Review decisions

Showing 50 results of 2493 total
Regulatory Decision Summary for Corzyna
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759938964937
Product Type: Drug
Control Number: 264421
DIN(s): 02510219, 02510227
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-19
Decision / Authorization Date: 2025-06-30
Regulatory Decision Summary for Xipere
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753456518317
Product Type: Drug
Control Number: 280633
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-11-06
Decision / Authorization Date: 2025-07-15
Regulatory Decision Summary for Amivas-Artesunate
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753987106919
Product Type: Drug
Control Number: 285622
Manufacturer: Amivas Ireland Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-04-03
Decision / Authorization Date: 2025-07-04
Regulatory Decision Summary for Rystiggo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752862833837
Product Type: Drug
Control Number: 274979
DIN(s): 02556081
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-10-06
Decision / Authorization Date: 2025-03-28
Regulatory Decision Summary for Aflivu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752764358755
Product Type: Drug
Control Number: 282152
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-18
Decision / Authorization Date: 2025-06-26
Regulatory Decision Summary for Pavblu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1754402562527
Product Type: Drug
Control Number: 276955
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-24
Decision / Authorization Date: 2025-07-08
Regulatory Decision Summary for Biktarvy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753294235039
Product Type: Drug
Control Number: 288709
DIN(s): 02478579
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-18
Decision / Authorization Date: 2025-06-10
Regulatory Decision Summary for Nduvra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753984288289
Product Type: Drug
Control Number: 272063
DIN(s): 02448254
Manufacturer: Dermavant Sciences GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2025-04-03
Regulatory Decision Summary for Baxdela
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753468201948
Product Type: Drug
Control Number: 284667
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-05
Decision / Authorization Date: 2025-01-17
Summary Safety Review - Nitric Oxide and Treprostinil - Assessing the Potential Risk of Pulmonary Edema in Patients with Pulmonary Veno-occlusive Disease
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1750181972356
DIN(s): 02246552, 02246553, 02246554, 02246555, 02270846, 02451301, 02451328, 02523841, 02523868, 02523876, 02523884
Issued / Original Publication Date: 2025-06-25
Updated Date: 2025-06-25

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