Review decisions

Showing 160 results of 2627 total
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
Summary Basis of Decision for Redemplo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1775662728537
Product Type: Drug
Control Number: 298667
Manufacturer: Arrowhead Pharmaceuticals, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2025-06-04
Issued / Original Publication Date: 2026-04-07
Decision / Authorization Date: 2026-01-02
Summary Safety Review - Gadolinium-based Contrast Agents - Assessing the Potential Risk of Serious Adverse Reactions, Including Seizures, Encephalopathy, Coma and Death, with Intrathecal Use
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1747762855840
DIN(s): 01989987, 02172771, 02229056, 02241089, 02248302, 02340666, 02459329, 02553678
Issued / Original Publication Date: 2025-05-30
Updated Date: 2025-05-30
Summary Safety Review - Stivarga (regorafenib) - Assessing the Potential Risk of Thrombotic Microangiopathy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1746542979258
DIN(s): 02403390
Issued / Original Publication Date: 2025-05-22
Updated Date: 2025-05-22
Regulatory Decision Summary for Alecensaro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758909378800
Product Type: Drug
Control Number: 282375
DIN(s): 02458136
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-27

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