Review decisions

Showing 830 results of 2304 total
Regulatory Decision Summary for Adacel
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00705
Product Type: Drug
Control Number: 220103
Manufacturer: Sanofi Pasteur Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-09-18
Decision / Authorization Date: 2020-09-25
Summary Basis of Decision for Bambevi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00568
Product Type: Drug
Control Number: 244450
DIN(s): 02520729, 02520737
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-09-25
Issued / Original Publication Date: 2022-01-11
Decision / Authorization Date: 2021-09-23
Updated Date: 2023-08-30
Regulatory Decision Summary for Bivalirudin Injection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00817
Product Type: Drug
Control Number: 232423
DIN(s): 02505517
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-10-09
Decision / Authorization Date: 2020-09-24
Summary Safety Review - Mesalazine-containing products - Assessing the Potential Risk of Birth Defects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00247
Issued / Original Publication Date: 2020-09-24
Regulatory Decision Summary for Incruse Ellipta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00759
Product Type: Drug
Control Number: 222505
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-11-29
Decision / Authorization Date: 2020-09-23
Summary Basis of Decision for Qinlock
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00497
Product Type: Drug
Control Number: 234688
DIN(s): 02500833
Manufacturer: Deciphera Pharmaceuticals, LLC
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-09-22
Summary Basis of Decision for Abecma
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00557
Product Type: Drug
Control Number: 244266
DIN(s): 02516233
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2020-09-22
Issued / Original Publication Date: 2021-11-22
Decision / Authorization Date: 2021-05-26
Updated Date: 2024-01-05
Regulatory Decision Summary for Imfinzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00696
Product Type: Drug
Control Number: 233107
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-11-01
Decision / Authorization Date: 2020-09-21
Summary Safety Review - Single Incision Mini-sling - Assessing the Long-term (beyond 3 years) Safety and Effectiveness
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00246
Issued / Original Publication Date: 2020-09-18
Regulatory Decision Summary for Emgality
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00706
Product Type: Drug
Control Number: 232324
DIN(s): 02505134
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-10-07
Decision / Authorization Date: 2020-09-17

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