Review decisions

Showing 2080 results of 2627 total
Summary Safety Review - TYSABRI (natalizumab) - Assessing the Potential Risk of Hemolytic Anemia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00094
Issued / Original Publication Date: 2016-06-06
Regulatory Decision Summary for INVOKAMET
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00127
Product Type: Drug
Control Number: 185383
DIN(s): 02455404, 02455420, 02455439, 02455455
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-06-11
Decision / Authorization Date: 2016-06-01
Regulatory Decision Summary for BRENZYS (sb4)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00153
Product Type: Drug
Control Number: 184793
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-06-08
Decision / Authorization Date: 2016-06-01
Summary Basis of Decision for Trumenba
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00368
Product Type: Drug
Control Number: 195550
DIN(s): 02468751
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-05-31
Issued / Original Publication Date: 2017-11-24
Decision / Authorization Date: 2017-10-05
Updated Date: 2024-08-15
Regulatory Decision Summary for BRILINTA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00139
Product Type: Drug
Control Number: 184666
DIN(s): 02455005
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-05-27
Decision / Authorization Date: 2016-05-30
Regulatory Decision Summary for TALTZ
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00123
Product Type: Drug
Control Number: 184993
DIN(s): 02455102, 02455110
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-06-01
Decision / Authorization Date: 2016-05-25
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

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