Review decisions

Showing 2090 results of 2627 total
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
Regulatory Decision Summary for KEYTRUDA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00087
Product Type: Drug
Control Number: 187844
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-09-18
Decision / Authorization Date: 2016-05-06
Summary Safety Review - Proton Pump Inhibitors - Assessing the Potential Risk of Clostridium difficile Infection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00069
Issued / Original Publication Date: 2016-05-06
Regulatory Decision Summary for ESBRIET
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00077
Product Type: Drug
Control Number: 184128
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-05-13
Decision / Authorization Date: 2016-05-02
Regulatory Decision Summary for LYNPARZA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00130
Product Type: Drug
Control Number: 182823
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Decision / Authorization Date: 2016-04-29

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