Review decisions

Showing 10 results of 2527 total
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 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
Regulatory Decision Summary for Lumakras
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764699279574
Product Type: Drug
Control Number: 276210
DIN(s): 02520095, 02552655
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-06-14
Decision / Authorization Date: 2024-10-28
Regulatory Decision Summary for Darzalex SC
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764349722993
Product Type: Drug
Control Number: 293030
DIN(s): 02502712
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-12-03
Decision / Authorization Date: 2025-11-18
Regulatory Decision Summary for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764697588695
Product Type: Drug
Control Number: 286962
DIN(s): 02512963, 02554267
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-05-30
Decision / Authorization Date: 2024-12-27
Regulatory Decision Summary for Tnkase
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764348115107
Product Type: Drug
Control Number: 288031
DIN(s): 02244826, 02562804
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-06-25
Decision / Authorization Date: 2025-11-13

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