Review decisions

Showing 1850 results of 2627 total
Regulatory Decision Summary for Kineret
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00247
Product Type: Drug
Control Number: 195649
DIN(s): 02245913
Manufacturer: Swedish Orphan Biovitrum AB (publ); Med-Script Associates Ltd. is filing on behalf of the sponsor.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-05-27
Decision / Authorization Date: 2017-05-18
Summary Basis of Decision for Brinavess
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00355
Product Type: Drug
Control Number: 190817
DIN(s): 02462400
Manufacturer: Cardiome UK Ltd.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-05-17
Updated Date: 2020-11-04
Regulatory Decision Summary for Mekinist
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00266
Product Type: Drug
Control Number: 199382
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-16
Regulatory Decision Summary for Tafinlar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00267
Product Type: Drug
Control Number: 199381
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-16
Regulatory Decision Summary for OPDIVO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00256
Product Type: Drug
Control Number: 199379
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2016-10-18
Decision / Authorization Date: 2017-05-12
Summary Basis of Decision for Rayaldee
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00409
Product Type: Drug
Control Number: 205392
DIN(s): 02478498
Manufacturer: Vifor Fresenius Medical Care Renal Pharma Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-09
Issued / Original Publication Date: 2018-11-27
Decision / Authorization Date: 2018-07-10
Updated Date: 2024-06-14
Regulatory Decision Summary for ACARIZAX
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00234
Product Type: Drug
Control Number: 195186
DIN(s): 02463644
Manufacturer: ALK-Abello A/S
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-16
Decision / Authorization Date: 2017-05-04
Summary Safety Review - XALKORI (crizotinib) - Assessing the potential risk of developing a hole in the bowel (gastrointestinal perforation)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00160
Issued / Original Publication Date: 2017-05-04
Summary Safety Review - Ear and Forehead (contact) Infrared Thermometers (various brands) - Assessing the potential risk of inaccuracy in children under 2 years old
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00159
Issued / Original Publication Date: 2017-05-03
Regulatory Decision Summary for Jentadueto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00265
Product Type: Drug
Control Number: 194067
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-04-08
Decision / Authorization Date: 2017-05-02

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