Review decisions

Showing 320 results of 2627 total
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 Verzenio
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722440238663
Product Type: Drug
Control Number: 249557
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-02-16
Decision / Authorization Date: 2022-01-12
Regulatory Decision Summary for Nordimet
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1743432929005
Product Type: Drug
Control Number: 262108
DIN(s): 02546531, 02546558, 02546566, 02546574, 02546582, 02546590, 02546604, 02546612
Manufacturer: Nordic Group B.V.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-14
Decision / Authorization Date: 2024-03-26
Regulatory Decision Summary for Ibrance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1743434762924
Product Type: Drug
Control Number: 273901
DIN(s): 02493535, 02493543, 02493551
Manufacturer: Pfizer Canada ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2024-03-07
Regulatory Decision Summary for Ferinject
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1741613420853
Product Type: Drug
Control Number: 272960
DIN(s): 02546078
Manufacturer: Vifor (International) Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-01
Decision / Authorization Date: 2024-03-11
Summary Basis of Decision for Iqirvo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751981071024
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-04-25
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
Regulatory Decision Summary for Cosentyx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717506584978
Product Type: Drug
Control Number: 269287
DIN(s): 02438070, 02547724
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-01
Decision / Authorization Date: 2024-05-17

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