Review decisions

Showing 70 results of 2627 total
Regulatory Decision Summary for Zoryve
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1773243638118
Product Type: Drug
Control Number: 292646
DIN(s): 02537532, 02552566, 02556146
Manufacturer: Arcutis Canada, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-22
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 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
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 Metvix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1762525671043
Product Type: Drug
Control Number: 262828
DIN(s): 02323273
Manufacturer: Galderma Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-28
Decision / Authorization Date: 2023-02-17
Regulatory Decision Summary for Ojjaara
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764950027991
Product Type: Drug
Control Number: 281695
DIN(s): 02552965, 02552973, 02552981
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-30
Decision / Authorization Date: 2024-11-08
Regulatory Decision Summary for Mounjaro Kwikpen
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764700842360
Product Type: Drug
Control Number: 283968
DIN(s): 02551950, 02551969, 02551977, 02551985, 02551993, 02552000
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-16
Decision / Authorization Date: 2024-09-24
Regulatory Decision Summary for Fruzaqla
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764698444664
Product Type: Drug
Control Number: 275803
DIN(s): 02551454, 02551462
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-14
Decision / Authorization Date: 2024-09-10

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