Review decisions

Showing 40 results of 2270 total
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
Regulatory Decision Summary for Brukinsa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1717694387694
Product Type: Drug
Control Number: 273215
DIN(s): 02512963
Manufacturer: Beigene Switzerland GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-10
Decision / Authorization Date: 2024-02-02
Regulatory Decision Summary for Truqap
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718733982360
Product Type: Drug
Control Number: 274859
DIN(s): 02544733, 02544741
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-28
Decision / Authorization Date: 2024-01-26
Regulatory Decision Summary for Mirena
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718716557847
Product Type: Drug
Control Number: 273103
DIN(s): 02243005
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-07
Decision / Authorization Date: 2024-02-20
Summary Safety Review - Nexavar (sorafenib) - Assessing the Potential Risk of Tumour Lysis Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1715006032208
DIN(s): 02284227
Issued / Original Publication Date: 2024-05-16
Updated Date: 2024-05-16
Regulatory Decision Summary for Okedi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722527517248
Product Type: Drug
Control Number: 264840
DIN(s): 02544601, 02544628
Manufacturer: Laboratorios Farmaceuticos Rovi, S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-03
Decision / Authorization Date: 2024-03-21
Regulatory Decision Summary for Qulipta
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722529358548
Product Type: Drug
Control Number: 273484
DIN(s): 02533979, 02533987, 02533995
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-03-20
Decision / Authorization Date: 2024-05-02

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