Review decisions

Showing 840 results of 2631 total
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
Regulatory Decision Summary for Ogivri
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00910
Product Type: Drug
Control Number: 247842
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-23
Decision / Authorization Date: 2021-12-06
Summary Basis of Decision for Paxlovid
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00577
Product Type: Drug
Control Number: 259186
DIN(s): 02524031, 02527804
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2021-12-01
Issued / Original Publication Date: 2022-02-28
Decision / Authorization Date: 2022-01-17
Updated Date: 2025-05-16
Regulatory Decision Summary for Saphnelo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00897
Product Type: Drug
Control Number: 246187
DIN(s): 02522845
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-09
Decision / Authorization Date: 2021-11-30
Regulatory Decision Summary for Influvac Tetra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00898
Product Type: Drug
Control Number: 246936
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-11-30
Decision / Authorization Date: 2021-11-30
Regulatory Decision Summary for Aybintio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00900
Product Type: Drug
Control Number: 247369
DIN(s): 02522829, 02522837
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-11-12
Decision / Authorization Date: 2021-11-30
Regulatory Decision Summary for TPOXX
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00955
Product Type: Drug
Control Number: 247561
DIN(s): 02522772
Manufacturer: SIGA Technologies, Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2020-12-22
Decision / Authorization Date: 2021-11-29

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