Review decisions

Showing 960 results of 2304 total
Regulatory Decision Summary for Suvexx
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00698
Product Type: Drug
Control Number: 225848
DIN(s): 02496305
Manufacturer: Aralez Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2019-03-20
Decision / Authorization Date: 2020-02-27
Summary Basis of Decision for Ontruzant
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00591
Product Type: Drug
Control Number: 235995
DIN(s): 02524317, 02524325
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-02-27
Issued / Original Publication Date: 2022-06-23
Decision / Authorization Date: 2022-01-28
Updated Date: 2024-06-13
Regulatory Decision Summary for Fiasp
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00638
Product Type: Drug
Control Number: 226586
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-04-04
Decision / Authorization Date: 2020-02-26
Regulatory Decision Summary for Mvasi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00619
Product Type: Drug
Control Number: 230254
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-08-21
Decision / Authorization Date: 2020-02-21
Regulatory Decision Summary for Influvac Tetra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00613
Product Type: Drug
Control Number: 225528
Manufacturer: BGP Pharma ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2019-03-08
Decision / Authorization Date: 2020-02-20
Regulatory Decision Summary for Mayzent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00648
Product Type: Drug
Control Number: 223225
DIN(s): 02496429, 02496437
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-12-21
Decision / Authorization Date: 2020-02-20
Regulatory Decision Summary for Nubeqa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00798
Product Type: Drug
Control Number: 226146
DIN(s): 02496348
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-03-27
Decision / Authorization Date: 2020-02-20
Regulatory Decision Summary for Xofluza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00631
Product Type: Drug
Control Number: 227361
DIN(s): 02496364, 02496372
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-04-30
Decision / Authorization Date: 2020-02-19
Summary Basis of Decision for Nextstellis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00536
Product Type: Drug
Control Number: 236197
DIN(s): 02513218
Manufacturer: Searchlight Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2020-02-18
Issued / Original Publication Date: 2021-06-16
Decision / Authorization Date: 2021-03-05
Updated Date: 2023-07-21
Summary Safety Review - Direct-acting antivirals - Assessing the potential risk of abnormal blood sugar levels (dysglycemia)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00234
Issued / Original Publication Date: 2020-02-17

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