Review decisions

Showing 20 results of 2561 total
Regulatory Decision Summary for Ixchiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765205479281
Product Type: Drug
Control Number: 290364
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-23
Decision / Authorization Date: 2025-08-14
Regulatory Decision Summary for BiCNU
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768236073374
Product Type: Drug
Control Number: 280995
DIN(s): 00297763, 02555093
Manufacturer: Marcan Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-10
Decision / Authorization Date: 2025-02-05
Regulatory Decision Summary for Augtyro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1768243878335
Product Type: Drug
Control Number: 284373
DIN(s): 02557444, 02557452
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-02-28
Decision / Authorization Date: 2025-05-07
Regulatory Decision Summary for Winrevair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765391179751
Product Type: Drug
Control Number: 298213
DIN(s): 02551284, 02551292, 02551306, 02551314
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-20
Decision / Authorization Date: 2025-12-03
Regulatory Decision Summary for Wegovy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764967113004
Product Type: Drug
Control Number: 279915
DIN(s): 02522551, 02522578, 02522586, 02522594, 02522608, 02528509, 02528517, 02528525, 02528533, 02528541, 02552698
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-13
Decision / Authorization Date: 2024-11-25
Summary Safety Review - Brukinsa (zanubrutinib), Calquence (acalabrutinib) and Imbruvica (ibrutinib) - Bruton’s Tyrosine Kinase (BTK) Inhibitors - Assessing the Potential Risk of Serious Hepatotoxicity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1762956369249
DIN(s): 02434407, 02486733, 02486741, 02486768, 02486776, 02491788, 02512963, 02535696, 02540215, 02554267, 02562006, 02562014
Issued / Original Publication Date: 2025-11-26
Updated Date: 2025-11-26
Regulatory Decision Summary for Ahzantive
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764180843562
Product Type: Drug
Control Number: 292152
DIN(s): 02562928
Manufacturer: Valorum Biologics LLC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-11-29
Decision / Authorization Date: 2025-11-19
Regulatory Decision Summary for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1765901981864
Product Type: Drug
Control Number: 290251
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-09-09
Decision / Authorization Date: 2025-04-08
Regulatory Decision Summary for Osenvelt
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1767624096300
Product Type: Drug
Control Number: 278930
DIN(s): 02560895
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Decision / Authorization Date: 2025-09-17
Regulatory Decision Summary for Stoboclo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1767625367645
Product Type: Drug
Control Number: 282455
DIN(s): 02560917
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Decision / Authorization Date: 2025-09-17

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