Review decisions

Showing 2070 results of 2627 total
Regulatory Decision Summary for EMPLICITI
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00145
Product Type: Drug
Control Number: 188144
DIN(s): 02455919, 02455927
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-10-01
Decision / Authorization Date: 2016-06-21
Regulatory Decision Summary for CORTIMENT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00167
Product Type: Drug
Control Number: 183534
DIN(s): 02455889
Manufacturer: Ferring Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-05-04
Decision / Authorization Date: 2016-06-20
Regulatory Decision Summary for MSM Blood Donor Deferral
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00121
Product Type: Drug
Control Number: 193844 & 193718
Submission Type: Application for an Authorization Amendment
Decision / Authorization Date: 2016-06-16
Regulatory Decision Summary for HARVONI
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00174
Product Type: Drug
Control Number: 190246
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-12-07
Decision / Authorization Date: 2016-06-14
Regulatory Decision Summary for DYSPORT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00116
Product Type: Drug
Control Number: 185877
DIN(s): 02387735, 02456117
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-20
Decision / Authorization Date: 2016-06-13
Regulatory Decision Summary for DYSPORT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00117
Product Type: Drug
Control Number: 185878
DIN(s): 02387735, 02456117
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-20
Decision / Authorization Date: 2016-06-13
Summary Safety Review - ULORIC (febuxostat) - Assessing a Possible Risk of Drug Reaction/Rash with Eosinophilia and Systemic Symptoms (DRESS)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00091
Issued / Original Publication Date: 2016-06-13
Regulatory Decision Summary for INFLECTRA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00124
Product Type: Drug
Control Number: 184564
Manufacturer: Celltrion Healthcare Co., Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-08-07
Decision / Authorization Date: 2016-06-10
Summary Safety Review - Hydroxyzine (ATARAX and generics) - Assessing the Potential Risk of Abnormal Heart Rhythm
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00092
Issued / Original Publication Date: 2016-06-06
Summary Safety Review - Denosumab (Prolia and Xgeva) - Hearing loss and deafness
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00093
Issued / Original Publication Date: 2016-06-06

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