Review decisions

Showing 2090 results of 2631 total
Summary Safety Review - ESSURE Permanent Birth Control System - Assessing the Risk of Complications Including Allergic Reactions, Abnormal Bleeding/Menstrual Changes and the Potential Need for Device Removal
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00061
Issued / Original Publication Date: 2016-05-25
Summary Basis of Decision for Siliq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00394
Product Type: Drug
Control Number: 195317
DIN(s): 02473623
Manufacturer: Valeant Canada LP
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-05-24
Issued / Original Publication Date: 2018-06-11
Decision / Authorization Date: 2018-03-06
Updated Date: 2025-08-19
Regulatory Decision Summary for AFINITOR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00115
Product Type: Drug
Control Number: 188629
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-10-19
Decision / Authorization Date: 2016-05-17
Regulatory Decision Summary for METOJECT SUBCUTANEOUS
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00120
Product Type: Drug
Control Number: 173985
DIN(s): 02454750, 02454769, 02454777, 02454823, 02454831, 02454858, 02454866, 02454874
Manufacturer: Medexus Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-04-30
Decision / Authorization Date: 2016-05-17
Regulatory Decision Summary for DAKLINZA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00141
Product Type: Drug
Control Number: 189173
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-11-05
Decision / Authorization Date: 2016-05-17
Summary Safety Review - SGLT2 Inhibitors (canagliflozin, dapagliflozin, empagliflozin) - Assessing the Risk of the Body Producing High Levels of Acids in the Blood (diabetic ketoacidosis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00013
Issued / Original Publication Date: 2016-05-16
Regulatory Decision Summary for ZONTIVITY
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00136
Product Type: Drug
Control Number: 179320
DIN(s): 02454815
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-31
Decision / Authorization Date: 2016-05-13
Summary Safety Review - Topical Antiseptic Non-Prescription Chlorhexidine Products - Assessing the Potential Risk of Serious Allergic Reactions (hypersensitivity reactions)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00065
Issued / Original Publication Date: 2016-05-13
Regulatory Decision Summary for EDURANT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00118
Product Type: Drug
Control Number: 185031
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-06-02
Decision / Authorization Date: 2016-05-10
Summary Safety Review - EYLEA (aflibercept) - Assessing the Risk of Side Effects Outside the Eye (systemic side effects)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00067
Issued / Original Publication Date: 2016-05-10

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