Review decisions

Showing 20 results of 2227 total
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
Summary Safety Review - Iodinated Contrast Medium - Assessing the Potential Risk of Hypothyroidism in Children Under 3 Years of Age
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1714657204971
DIN(s): 00386685, 00397466, 01900854, 02035626, 02078600, 02078619, 02145766, 02145774, 02172739, 02172747, 02172755, 02228564, 02229013, 02229021, 02229048, 02242121, 02242122, 02387441
Issued / Original Publication Date: 2024-05-10
Updated Date: 2024-05-10
Regulatory Decision Summary for Teva-Sapropterin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1718027763592
Product Type: Drug
Control Number: 265907
Manufacturer: Teva Canada Limited
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2022-09-01
Decision / Authorization Date: 2024-05-03
Regulatory Decision Summary for Zejula
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1716577628323
Product Type: Drug
Control Number: 262892
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-03-30
Decision / Authorization Date: 2024-01-12
Regulatory Decision Summary for Niopeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714499567288
Product Type: Drug
Control Number: 262438
DIN(s): 02546973
Manufacturer: Nora Pharma
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-17
Decision / Authorization Date: 2024-04-17
Regulatory Decision Summary for Skyrizi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1714053364853
Product Type: Drug
Control Number: 274993
DIN(s): 02546922
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-03
Decision / Authorization Date: 2024-04-05

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