Review decisions

Showing 1830 results of 2627 total
Summary Safety Review - BRILINTA (ticagrelor) - Assessing the Potential Risk of Severe Skin Side Effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00166
Issued / Original Publication Date: 2017-06-26
Summary Basis of Decision for Eucrisa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00406
Product Type: Drug
Control Number: 206906
DIN(s): 02476991
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-06-23
Issued / Original Publication Date: 2018-10-18
Decision / Authorization Date: 2018-06-07
Updated Date: 2025-07-24
Summary Safety Review - Finasteride - Assessing the Potential Risk of Serious Muscle-Related Side Effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00164
Issued / Original Publication Date: 2017-06-22
Summary Safety Review - TYSABRI (natalizumab) - Blood (hematological) Abnormalities in Newborns whose Mothers were treated with Tysabri During Pregnancy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00165
Issued / Original Publication Date: 2017-06-22
Regulatory Decision Summary for Belbuca
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00272
Product Type: Drug
Control Number: 196428
DIN(s): 02465221, 02465248, 02465256, 02465264, 02465272, 02465280, 02465299
Manufacturer: Paladin Labs Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-06-30
Decision / Authorization Date: 2017-06-21
Regulatory Decision Summary for Victoza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00255
Product Type: Drug
Control Number: 196457
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-06-30
Decision / Authorization Date: 2017-06-15
Summary Safety Review - TECFIDERA - Assessing the Potential Risk of Kidney Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00162
Issued / Original Publication Date: 2017-06-15
Updated Date: 2017-06-30
Summary Safety Review - Dipeptidylpeptidase-4 (DPP-4) Inhibitors - Assessing the Potential Risk of Heart Failure
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00163
Issued / Original Publication Date: 2017-06-15
Regulatory Decision Summary for PMS-Fluoxetine
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00413
Product Type: Drug
Control Number: 198520
DIN(s): 02464640, 02464659
Manufacturer: Pharmascience Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-09-21
Decision / Authorization Date: 2017-06-13
Regulatory Decision Summary for Procysbi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00264
Product Type: Drug
Control Number: 191347
DIN(s): 02464705, 02464713
Manufacturer: Horizon Pharma Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-01-21
Decision / Authorization Date: 2017-06-13

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