Review decisions

Showing 2280 results of 2627 total
Regulatory Decision Summary for Movantik
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00033
Product Type: Drug
Control Number: 167790
DIN(s): 02442167, 02442175
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2013-08-30
Decision / Authorization Date: 2015-06-02
Regulatory Decision Summary for INSPIOLTO RESPIMAT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00027
Product Type: Drug
Control Number: 173315
DIN(s): 02441888
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-09
Decision / Authorization Date: 2015-06-01
Summary Safety Review - PROLIA (denosumab) - Cardiovascular events
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00026
Issued / Original Publication Date: 2015-05-29
Regulatory Decision Summary for TOUJEO SoloSTAR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00053
Product Type: Drug
Control Number: 173316
DIN(s): 02441829
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-13
Decision / Authorization Date: 2015-05-28
Summary Safety Review - NEXAVAR (sorafenib) - Thyroid Gland Dysfunction
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00027
Issued / Original Publication Date: 2015-05-28
Summary Safety Review - ULORIC (febuxostat) - Agranulocytosis (severe reduction in the number of white blood cells)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00028
Issued / Original Publication Date: 2015-05-28
Regulatory Decision Summary for Spiriva Respimat
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00049
Product Type: Drug
Control Number: 175084
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-05-23
Decision / Authorization Date: 2015-05-20
Regulatory Decision Summary for KEYTRUDA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00031
Product Type: Drug
Control Number: 175884
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission - Notice of Compliance with Conditions
Date Filed / Submission Date: 2014-06-20
Decision / Authorization Date: 2015-05-19
Regulatory Decision Summary for Avastin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00008
Product Type: Drug
Control Number: 170054
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2013-11-15
Decision / Authorization Date: 2015-05-15
Summary Safety Review - SEVORANE AF (sevoflurane) - Severe low heart rate in children with Down syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00029
Issued / Original Publication Date: 2015-05-13

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