Review decisions

Showing 130 results of 2627 total
Regulatory Decision Summary for Tyruko (natalizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760451879250
Product Type: Drug
Control Number: 286523
DIN(s): 02561123
Manufacturer: Polpharma Biologics S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-01
Decision / Authorization Date: 2025-09-24
Regulatory Decision Summary for Bridion
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764954565408
Product Type: Drug
Control Number: 289615
DIN(s): 02451816
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-08-15
Decision / Authorization Date: 2025-07-31
Regulatory Decision Summary for Spevigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1770305064136
Product Type: Drug
Control Number: 278317
DIN(s): 02536455, 02550296, 02561697
Manufacturer: Boehringer Ingelheim (Canada) Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-17
Decision / Authorization Date: 2024-07-31
Regulatory Decision Summary for Kadian
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1764952797915
Product Type: Drug
Control Number: 293099
DIN(s): 02184435, 02184443, 02184451, 02242163, 02559722
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-12-05
Decision / Authorization Date: 2025-07-25
Regulatory Decision Summary for Elyxyb
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1767629736618
Product Type: Drug
Control Number: 280702
DIN(s): 02556804
Manufacturer: Scilex Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2025-04-09
Regulatory Decision Summary for Andembry
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758639086697
Product Type: Drug
Control Number: 280174
Manufacturer: CSL Behring Canada Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-14
Decision / Authorization Date: 2025-08-06
Regulatory Decision Summary for Tremfya / Tremfya One-Press / Tremfya I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759849486740
Product Type: Drug
Control Number: 288802
DIN(s): 02559137, 02559145, 02559153
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-22
Decision / Authorization Date: 2025-07-07
Summary Safety Review - Garcinia gummi-gutta and Hydroxycitric Acid - Assessing the Potential Risk of Hepatotoxicity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1755272782909
Issued / Original Publication Date: 2025-09-19
Updated Date: 2025-09-19
Regulatory Decision Summary for Yesafili
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758225540975
Product Type: Drug
Control Number: 259183
DIN(s): 02535858
Manufacturer: Biosimilar Collaborations Ireland Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-16
Decision / Authorization Date: 2025-06-26
Regulatory Decision Summary for Itulatek
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758129348534
Product Type: Drug
Control Number: 287138
DIN(s): 02498073
Manufacturer: ALK- Abello A/S
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-05-24
Decision / Authorization Date: 2025-05-02

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