Review decisions

Showing 2330 results of 2627 total
Summary Safety Review - Vascular Endothelial Growth Factor Receptor Inhibitors - Thrombotic Microangiopathy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00044
Issued / Original Publication Date: 2015-01-14
Summary Basis of Decision for Harvoni
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00249
Product Type: Drug
Control Number: 173180
DIN(s): 02432226
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-01-12
Updated Date: 2022-10-28
Summary Basis of Decision for Lenvima
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00209
Product Type: Drug
Control Number: 180877
DIN(s): 02450291, 02450305, 02450313, 02450321, 02468220, 02468239, 02484056, 02484129
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-01-08
Issued / Original Publication Date: 2016-02-09
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-03-03
Summary Basis of Decision for Bridion
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00283
Product Type: Drug
Control Number: 180385
DIN(s): 02451816
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-12-23
Issued / Original Publication Date: 2016-05-13
Decision / Authorization Date: 2016-02-05
Updated Date: 2025-07-15
Summary Basis of Decision for Opdivo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00293
Product Type: Drug
Control Number: 180828
DIN(s): 02446626, 02446634, 02557320
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-12-19
Issued / Original Publication Date: 2016-01-08
Decision / Authorization Date: 2015-09-25
Updated Date: 2026-03-30
Summary Basis of Decision for Revestive
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00267
Product Type: Drug
Control Number: 180223
DIN(s): 02445727
Manufacturer: NPS Pharma Holdings Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-12-09
Issued / Original Publication Date: 2015-11-09
Decision / Authorization Date: 2015-09-04
Updated Date: 2023-04-11
Summary Safety Review - Hydroxyethyl Starch Solutions - Risk of Kidney Injury and Death
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00045
Issued / Original Publication Date: 2014-12-03
Summary Safety Review - YERVOY (ipilimumab) - Posterior Reversible Encephalopathy Syndrome (PRES)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00046
Issued / Original Publication Date: 2014-12-01
Summary Safety Review - STELARA (ustekinumab) - Serious Skin Disorders (Exfoliative Dermatitis and Erythrodermic Psoriasis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00047
Issued / Original Publication Date: 2014-11-24
Summary Safety Review - IMOVANE (zopiclone) - Next-Day Impairment
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00048
Issued / Original Publication Date: 2014-11-21

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