Review decisions

Showing 2030 results of 2631 total
Regulatory Decision Summary for GENTAMICIN INJECTION USP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00157
Product Type: Drug
Control Number: 183885
DIN(s): 02457008
Manufacturer: Teligent OÜ
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-17
Decision / Authorization Date: 2016-08-19
Summary Safety Review - GILENYA (fingolimod) - Assessing the Potential Risk of a Rare Brain Infection (Progressive Multifocal Leukoencephalopathy)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00108
Issued / Original Publication Date: 2016-08-19
Summary Basis of Decision for Evenity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00451
Product Type: Drug
Control Number: 197713
DIN(s): 02489597
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-08-18
Issued / Original Publication Date: 2019-11-21
Decision / Authorization Date: 2019-06-17
Updated Date: 2025-07-31
Regulatory Decision Summary for ALPROLIX
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00147
Product Type: Drug
Control Number: 188247
Manufacturer: Biogen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-19
Decision / Authorization Date: 2016-08-16
Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Sleep Apnoea
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00110
Issued / Original Publication Date: 2016-08-16
Summary Safety Review - INTUNIV XR (guanfacine hydrochloride) - Assessing the Potential Risk of Raynaud's Phenomenon
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00111
Issued / Original Publication Date: 2016-08-15
Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early Wear
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00112
Issued / Original Publication Date: 2016-08-15
Summary Safety Review - Antidepressants - Assessing the Potential Risk of Serious Eye Disorder (Angle-Closure Glaucoma)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00113
Issued / Original Publication Date: 2016-08-12
Summary Safety Review - Hormone Replacement Therapy (Estrogenic and Progestogenic Agents) and Selective Estrogen Receptor Modulators (SERMs) - Assessing the Potential Risk of Ovarian Cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00114
Issued / Original Publication Date: 2016-08-09
Summary Basis of Decision for Praxbind
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00322
Product Type: Drug
Control Number: 182503
DIN(s): 02454343
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-08-08
Updated Date: 2020-12-02

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