Review decisions

Showing 830 results of 2627 total
Summary Safety Review - Domperidone - Assessing the Potential Risks of Serious Ventricular Arrhythmias, QT Interval Prolongation and Sudden Cardiac Death
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00277
Issued / Original Publication Date: 2021-12-30
Updated Date: 2022-12-08
Summary Basis of Decision for Sibboran
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1719939219034
Product Type: Drug
Control Number: 259953
DIN(s): 02543338
Manufacturer: Trimedic Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-30
Issued / Original Publication Date: 2024-07-02
Decision / Authorization Date: 2023-11-20
Updated Date: 2025-01-21
Summary Basis of Decision for Vegzelma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684869579695
Product Type: Drug
Control Number: 258973
DIN(s): 02534177, 02534185
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-12-29
Issued / Original Publication Date: 2023-05-02
Decision / Authorization Date: 2023-01-03
Updated Date: 2025-08-19
Regulatory Decision Summary for Yuflyma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00906
Product Type: Drug
Control Number: 247265
DIN(s): 02523760, 02523779
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-12
Decision / Authorization Date: 2021-12-24
Regulatory Decision Summary for Ixifi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00901
Product Type: Drug
Control Number: 248134
DIN(s): 02523191
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-01-08
Decision / Authorization Date: 2021-12-21
Regulatory Decision Summary for Jardiance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1692123802448
Product Type: Drug
Control Number: 246457
DIN(s): 02443937, 02443945
Manufacturer: Boehringer Ingelheim (Canada) Ltd Ltee
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-11-16
Decision / Authorization Date: 2021-10-29
Summary Basis of Decision for Livtencity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00625
Product Type: Drug
Control Number: 259676
DIN(s): 02530740
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-16
Issued / Original Publication Date: 2023-02-17
Decision / Authorization Date: 2022-09-15
Updated Date: 2024-11-21
Summary Safety Review - Amoxicillin-containing Products - Assessing the Potential Risk of Aseptic Meningitis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00276
Issued / Original Publication Date: 2021-12-10
Summary Safety Review - Aimovig (erenumab) - Assessing the Potential Risks of Non-Fatal Stroke, Non-Fatal Heart Attack and Cardiovascular Death
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00275
Issued / Original Publication Date: 2021-12-08
Updated Date: 2021-12-17
Summary Basis of Decision for Sotyktu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00628
Product Type: Drug
Control Number: 259397
DIN(s): 02533030
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-12-08
Issued / Original Publication Date: 2023-03-10
Decision / Authorization Date: 2022-11-24
Updated Date: 2024-06-10

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