Review decisions

Showing 1190 results of 2632 total
Regulatory Decision Summary for SmofKabiven, SmofKabiven extra Nitrogen
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00787
Product Type: Drug
Control Number: 230147
DIN(s): 02501813
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-30
Decision / Authorization Date: 2020-07-09
Regulatory Decision Summary for Smofkabiven Electrolyte Free, Smofkabiven extra Nitrogen Electrolyte Free
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00794
Product Type: Drug
Control Number: 230307
DIN(s): 02501775
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-01
Decision / Authorization Date: 2020-07-09
Summary Safety Review - Brilinta (ticagrelor) - Assessing the Potential Risks of a Worsening of a Slow and Irregular Heartbeat (Bradyarrhythmia) and Partial or Complete Block in the Transmission of Heart Impulses (Second- and Third-Degree Atrioventricular Block)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00241
Issued / Original Publication Date: 2020-07-06
Regulatory Decision Summary for Enerzair Breezhaler
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00693
Product Type: Drug
Control Number: 228353
DIN(s): 02501244
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-07-22
Decision / Authorization Date: 2020-07-02
Summary Safety Review - Picato (ingenol mebutate) - Assessing the Potential Risk of Skin Cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00242
Issued / Original Publication Date: 2020-07-02
Regulatory Decision Summary for Avelumab (BAVENCIO)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00687
Product Type: Drug
Control Number: 226954
Manufacturer: EMD Serono, A Division of EMD Inc., Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-18
Decision / Authorization Date: 2020-06-30
Regulatory Decision Summary for Forxiga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00682
Product Type: Drug
Control Number: 234304
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2019-12-10
Decision / Authorization Date: 2020-06-30
Regulatory Decision Summary for Genotropin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00689
Product Type: Drug
Control Number: 229726
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-15
Decision / Authorization Date: 2020-06-22
Regulatory Decision Summary for Qinlock
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00879
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2019-12-23
Decision / Authorization Date: 2020-06-19
Summary Basis of Decision for Veklury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00491
Product Type: Drug
Control Number: 240551
DIN(s): 02502135, 02502143
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2020-08-19
Decision / Authorization Date: 2020-07-27
Updated Date: 2025-05-16

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