Review decisions

Showing 100 results of 292 total
Summary Safety Review - Propofol-containing products - Assessing the potential risk of prolonged erection of the penis (priapism)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00227
Issued / Original Publication Date: 2019-07-12
Summary Safety Review - Fluoroquinolones - Assessing the potential risk of aneurysm (a balloon-like bulge) and dissection (a separation or tear in the layers of the wall) of the aorta (a major blood vessel)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00226
Issued / Original Publication Date: 2019-06-27
Summary Safety Review - Opdivo (nivolumab) and Yervoy (ipilimumab) used alone, or in combination - Assessing the potential risk of Hemophagocytic Lymphohistiocytosis (HLH)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00225
Issued / Original Publication Date: 2019-06-24
Summary Safety Review - Gentian violet-containing human health products - Assessing the potential risk of cancer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00224
Issued / Original Publication Date: 2019-06-12
Updated Date: 2019-06-27
Summary Safety Review - Breast Implants - Assessing the potential risk of cancer (Breast implant associated anaplastic large cell lymphoma)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00223
Issued / Original Publication Date: 2019-05-28
Updated Date: 2019-05-30
Summary Safety Review - Cellex Photopheresis System and Venous Thromboembolism & Pulmonary Embolism
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00222
Issued / Original Publication Date: 2019-05-03
Summary Safety Review - Intragastric balloons - Assessing the potential risk of inflamed pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00221
Issued / Original Publication Date: 2019-04-17
Summary Safety Review - Opsumit (macitentan) - Assessing the potential risk of liver injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00220
Issued / Original Publication Date: 2019-03-01
Summary Safety Review - Gilenya (fingolimod) - Assessing the potential risk of worsening multiple sclerosis symptoms after product withdrawal (rebound effect)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00219
Issued / Original Publication Date: 2019-02-28
Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00218
Issued / Original Publication Date: 2019-02-26

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