Review decisions

Showing 840 results of 2304 total
Regulatory Decision Summary for Bijuva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01013
Product Type: Drug
Control Number: 224010
DIN(s): 02505215, 02505223
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-09-17
Decision / Authorization Date: 2020-09-17
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 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: 2023-09-13
Summary Basis of Decision for Enspryng
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00495
Product Type: Drug
Control Number: 233642
DIN(s): 02499681
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2020-09-08
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: 2023-08-17

Displaying 831 - 840 of 2304 | Page 84 of 231
Report a problem or mistake on this page
Please select all that apply:
Date modified: