Review decisions

Showing 2190 results of 2627 total
Regulatory Decision Summary for NUCALA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00131
Product Type: Drug
Control Number: 179850
DIN(s): 02449781
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-11-19
Decision / Authorization Date: 2015-12-03
Regulatory Decision Summary for FORXIGA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00079
Product Type: Drug
Control Number: 180758
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-17
Decision / Authorization Date: 2015-12-02
Summary Basis of Decision for Adynovate
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00340
Product Type: Drug
Control Number: 189709
DIN(s): 02459035, 02459043, 02459051, 02459078, 02498537, 02498545, 02498553, 02498561, 02498588, 02498596, 02498618, 02498626
Manufacturer: Baxalta Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-12-02
Issued / Original Publication Date: 2016-12-30
Decision / Authorization Date: 2016-11-17
Updated Date: 2023-11-01
Regulatory Decision Summary for FYCOMPA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00021
Product Type: Drug
Control Number: 180976
Manufacturer: Eisai Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-01-06
Decision / Authorization Date: 2015-12-01
Summary Safety Review - VOTRIENT (pazopanib) - Assessing the Potential Risk of Accumulation of Fluid Around the Heart (Pericardial Effusion)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00009
Issued / Original Publication Date: 2015-11-30
Summary Safety Review - AVASTIN (bevacizumab) - Assessing the Potential Risk of Irreversible Vocal Cord Damage (vocal cord necrosis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00010
Issued / Original Publication Date: 2015-11-30
Regulatory Decision Summary for INVEGA SUSTENNA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00125
Product Type: Drug
Control Number: 180916
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-23
Decision / Authorization Date: 2015-11-27
Regulatory Decision Summary for GENVOYA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00146
Product Type: Drug
Control Number: 181399
DIN(s): 02449498
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-01-19
Decision / Authorization Date: 2015-11-27
Regulatory Decision Summary for NIASTASE RT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00093
Product Type: Drug
Control Number: 180663
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-15
Decision / Authorization Date: 2015-11-25
Regulatory Decision Summary for JAKAVI
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00128
Product Type: Drug
Control Number: 180682
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-15
Decision / Authorization Date: 2015-11-24

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