Review decisions

Showing 10 results of 2227 total
Regulatory Decision Summary for Tecentriq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721931544640
Product Type: Drug
Control Number: 254159
DIN(s): 02462990, 02492393
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-06-25
Decision / Authorization Date: 2022-03-29
Regulatory Decision Summary for Praluent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1721416399864
Product Type: Drug
Control Number: 263226
DIN(s): 02547732
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-04-08
Decision / Authorization Date: 2024-05-15
Regulatory Decision Summary for Opdivo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1720539616626
Product Type: Drug
Control Number: 282374
DIN(s): 02446626, 02446634
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-28
Regulatory Decision Summary for Ixchiq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719926004455
Product Type: Drug
Control Number: 275762
DIN(s): 02548984
Manufacturer: Valneva Austria GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-29
Decision / Authorization Date: 2024-06-20
Regulatory Decision Summary for Keytruda
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719422939290
Product Type: Drug
Control Number: 276501
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-23
Decision / Authorization Date: 2024-05-29
Regulatory Decision Summary for Ebglyss (lebrikizumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719934782015
Product Type: Drug
Control Number: 272660
DIN(s): 02549123, 02549131
Manufacturer: Eli Lilly Canada, Inc.
Submission Type: New Drug Submission (New Active Submission)
Date Filed / Submission Date: 2022-02-22
Decision / Authorization Date: 2024-06-24
Regulatory Decision Summary for HyQvia (Immunoglobulin [Human] and Recombinant Human Hyaluronidase)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719321468799
Product Type: Drug
Control Number: 276884
DIN(s): 02524368, 02524376, 02524384, 02524392, 02524406
Manufacturer: Takeda Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-06-11
Regulatory Decision Summary for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1719947956895
Product Type: Drug
Control Number: 254556
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-07-09
Decision / Authorization Date: 2022-02-18
Summary Safety Review - Isotretinoin - Assessing the Potential Risk of Sexual Dysfunction, Including Persistent Sexual Dysfunction After Drug Discontinuation
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1717527382406
DIN(s): 00582344, 00582352, 02257955, 02257963, 02309173, 02396971, 02396998, 02397005, 02397013, 02539047, 02539055, 02539063, 02539071
Issued / Original Publication Date: 2024-06-07
Updated Date: 2024-06-07
Regulatory Decision Summary for Talvey
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717432595126
Product Type: Drug
Control Number: 278277
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-08-15
Decision / Authorization Date: 2024-04-30

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