Review decisions

Showing 2030 results of 2627 total

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

Regulatory Decision Summary for REMSIMA

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00177

Product Type: Drug

Control Number: 184568

Manufacturer: Celltrion Healthcare Co., Ltd.

Submission Type: Supplement to a New Drug Submission

Date Filed / Submission Date: 2015-08-07

Decision / Authorization Date: 2016-08-05

Summary Safety Review - Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg) - Assessing the Potential Risk of Seizures

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00115

Issued / Original Publication Date: 2016-08-05

Regulatory Decision Summary for NINLARO

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00148

Product Type: Drug

Control Number: 190498

DIN(s): 02456796, 02456818, 02456826

Manufacturer: Takeda Canada Inc.

Submission Type: New Drug Submission (New Active Substance) - Priority Review

Date Filed / Submission Date: 2015-12-14

Decision / Authorization Date: 2016-08-04

Summary Safety Review - ENBREL (etanercept) - Assessing the potential harm to the developing babies of mothers treated with ENBREL

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00098

Issued / Original Publication Date: 2016-08-04

Date modified:: 2026-04-21

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