Review decisions

Showing 1150 results of 2627 total
Regulatory Decision Summary for Bisoprolol fumarate (*JAMP BISOPROLOL)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00869
Product Type: Drug
Control Number: 231842
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-23
Decision / Authorization Date: 2020-09-16
Summary Safety Review - Imbruvica (ibrutinib) - Assessing the Potential Risk of Hemophagocytic Lymphohistiocytosis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00245
Issued / Original Publication Date: 2020-09-15
Regulatory Decision Summary for Trulicity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00702
Product Type: Drug
Control Number: 232128
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-10-02
Decision / Authorization Date: 2020-09-11
Summary Safety Review - Hydromorphone Controlled Release Capsules - Assessing the Increased Risk of Serious Infections Linked to the Injection of the Content of the Capsules into Veins
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00244
Issued / Original Publication Date: 2020-09-10
Summary Basis of Decision for Gavreto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00559
Product Type: Drug
Control Number: 243731
DIN(s): 02517590
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-26
Decision / Authorization Date: 2021-06-30
Updated Date: 2025-06-04
Summary Basis of Decision for Retevmo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749640931774
Product Type: Drug
Control Number: 243748
DIN(s): 02516918, 02516926
Manufacturer: Loxo Oncology, Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2021-11-09
Decision / Authorization Date: 2021-06-15
Updated Date: 2025-06-04
Summary Basis of Decision for Pemazyre
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00576
Product Type: Drug
Control Number: 242569
DIN(s): 02519933, 02519941, 02519968
Manufacturer: Incyte Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-10
Issued / Original Publication Date: 2022-02-16
Decision / Authorization Date: 2021-09-17
Updated Date: 2024-06-07
Summary Basis of Decision for Koselugo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00618
Product Type: Drug
Control Number: 243733
DIN(s): 02530139, 02530147
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-09-09
Issued / Original Publication Date: 2022-12-20
Decision / Authorization Date: 2022-08-31
Updated Date: 2024-11-22
Regulatory Decision Summary for Tremfya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00697
Product Type: Drug
Control Number: 232124
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-09-30
Decision / Authorization Date: 2020-09-04
Summary Basis of Decision for Leqvio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00556
Product Type: Drug
Control Number: 243470
DIN(s): 02518376
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-08-31
Issued / Original Publication Date: 2021-11-10
Decision / Authorization Date: 2021-07-26
Updated Date: 2025-02-26

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