Review decisions

Showing 1460 results of 2627 total
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
Regulatory Decision Summary for Vizimpro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00552
Product Type: Drug
Control Number: 214572
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-03-16
Decision / Authorization Date: 2019-02-26
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
Summary Basis of Decision for Ibsrela
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00492
Product Type: Drug
Control Number: 224850
DIN(s): 02498049
Manufacturer: Knight Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2019-02-26
Issued / Original Publication Date: 2020-08-24
Decision / Authorization Date: 2020-04-15
Updated Date: 2025-08-19
Summary Safety Review - Ferriprox (deferiprone) - Assessing the potential risk of brain and nervous system (neurological) disorders in children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00217
Issued / Original Publication Date: 2019-02-25
Regulatory Decision Summary for Rexulti
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00506
Product Type: Drug
Control Number: 205854
DIN(s): 02485923
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-05-23
Decision / Authorization Date: 2019-02-22
Regulatory Decision Summary for Lorbrena
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00554
Product Type: Drug
Control Number: 215733
DIN(s): 02485966, 02485974
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-26
Decision / Authorization Date: 2019-02-22
Regulatory Decision Summary for Cubicin, Cubicin RF
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00581
Product Type: Drug
Control Number: 214792
Manufacturer: Cubist Pharmaceuticals, Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-03-23
Decision / Authorization Date: 2019-02-21
Summary Safety Review - Opioid-containing cough and cold products - Assessing the potential risk of opioid use disorder and related harms in children and adolescents
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00216
Issued / Original Publication Date: 2019-02-18

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