Review decisions

Showing 2340 results of 2631 total

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: 2025-08-15

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

Summary Basis of Decision for Strensiq

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00190

Product Type: Drug

Control Number: 179340

DIN(s): 02444607, 02444615, 02444623, 02444631, 02444658

Manufacturer: Alexion Pharma International Sarl

Submission Type: New Drug Submission (New Active Substance)

Date Filed / Submission Date: 2014-10-30

Issued / Original Publication Date: 2015-10-21

Decision / Authorization Date: 2015-08-14

Updated Date: 2023-09-01

Summary Safety Review - Azithromycin - Drug Reaction/Rash with Eosinophilia and Systemic Symptoms (DRESS)

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00050

Issued / Original Publication Date: 2014-10-21

Summary Safety Review - Immunoglobulins - Risk of Blood Clots (Thrombosis)

https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00051

Issued / Original Publication Date: 2014-10-09

Date modified:: 2026-04-28

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