Review decisions

Showing 880 results of 2304 total
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: 2024-05-17
Summary Basis of Decision for Verquvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1692890357153
Product Type: Drug
Control Number: 240862
DIN(s): 02537044, 02537052, 02537060
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-06-19
Issued / Original Publication Date: 2023-08-22
Decision / Authorization Date: 2023-04-28
Summary Safety Review - Xeljanz and Xeljanz XR (tofacitinib) and Jakavi (ruxolitinib) - Janus Kinase (JAK) inhibitors - Assessing the Potential Risk of Blood Clots in the Deep Veins (Venous Thromboembolic Events)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00240
Issued / Original Publication Date: 2020-06-18
Regulatory Decision Summary for Crysvita
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00664
Product Type: Drug
Control Number: 229313
Manufacturer: Kyowa Kirin, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-07-10
Decision / Authorization Date: 2020-06-16

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