Review decisions

Showing 510 results of 2627 total
Summary Basis of Decision for Eydenzelt
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1773770309039
Product Type: Drug
Control Number: 274179
DIN(s): 02563037, 02563045
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-03
Issued / Original Publication Date: 2026-03-17
Decision / Authorization Date: 2025-11-24
Regulatory Decision Summary for Trodelvy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690902285653
Product Type: Drug
Control Number: 270849
DIN(s): 02520788
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-07-19
Regulatory Decision Summary for Idhifa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694097699416
Product Type: Drug
Control Number: 256961
Manufacturer: Celgene Inc. / Bristol-Myers Squibb
Submission Type: Supplement to a New Drug Submission - Confirmatory
Date Filed / Submission Date: 2021-09-23
Decision / Authorization Date: 2023-06-09
Regulatory Decision Summary for Akeega
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1694526985734
Product Type: Drug
Control Number: 265223
DIN(s): 02538555, 02538563
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-15
Decision / Authorization Date: 2023-06-12
Regulatory Decision Summary for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697217066787
Product Type: Drug
Control Number: 264963
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-06-07
Decision / Authorization Date: 2023-05-24
Regulatory Decision Summary for Lynparza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1697728420996
Product Type: Drug
Control Number: 265427
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc
Submission Type: Supplement to a New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2023-07-11
Regulatory Decision Summary for Omvoh
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1690554055228
Product Type: Drug
Control Number: 266471
DIN(s): 02539845, 02539853, 02539861
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-07-27
Decision / Authorization Date: 2023-07-20
Regulatory Decision Summary for Axberi / Axberi HP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1691593234367
Product Type: Drug
Control Number: 266545
DIN(s): 02539977, 02539985, 02540002, 02540010, 02540029, 02540037, 02540045
Manufacturer: Baxter Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-07-29
Decision / Authorization Date: 2023-07-27
Summary Safety Review - Tagrisso (osimertinib) - Assessing the Potential Risk of Rhabdomyolysis and Other Myopathy-related Events
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1690380271165
DIN(s): 02456214, 02456222
Issued / Original Publication Date: 2023-07-26
Updated Date: 2023-07-26
Regulatory Decision Summary for Prevnar 20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692295194036
Product Type: Drug
Control Number: 270922
DIN(s): 02527049
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-22
Decision / Authorization Date: 2023-07-21

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