Review decisions

Showing 2020 results of 2304 total
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
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: 2024-05-23
Summary Basis of Decision for Trintellix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00197
Product Type: Drug
Control Number: 159019
DIN(s): 02432919, 02432927, 02432935, 02432943
Manufacturer: Lundbeck Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2014-12-11
Updated Date: 2021-11-30
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
Summary Basis of Decision for Nucala
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00279
Product Type: Drug
Control Number: 179850
DIN(s): 02449781, 02492989, 02492997, 02530821
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-11-19
Issued / Original Publication Date: 2016-03-01
Decision / Authorization Date: 2015-12-03
Updated Date: 2023-08-14
Summary Safety Review - Sulfamethoxazole-Trimethoprim - Risk of Drug-induced Immune Thrombocytopenia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00049
Issued / Original Publication Date: 2014-11-18
Summary Basis of Decision for Amitiza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00337
Product Type: Drug
Control Number: 179333
Manufacturer: Sucampo Pharma Americas, LLC
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-10-31
Issued / Original Publication Date: 2015-12-24
Decision / Authorization Date: 2015-10-14
Updated Date: 2023-06-30

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