Review decisions

Showing 2320 results of 2627 total
Summary Basis of Decision for Ibrance
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00287
Product Type: Drug
Control Number: 182048
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-02-12
Issued / Original Publication Date: 2016-05-19
Decision / Authorization Date: 2016-03-16
Updated Date: 2025-05-12
Summary Basis of Decision for Idelvion
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00288
Product Type: Drug
Control Number: 180793
DIN(s): 02451336, 02451344, 02451352, 02451360, 02489627
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-09
Issued / Original Publication Date: 2016-03-09
Decision / Authorization Date: 2016-01-26
Updated Date: 2025-03-17
Summary Safety Review - Mycophenolates (CELLCEPT and MYFORTIC) - Bronchiectasis (Damage to the Lung Airways) with or without Hypogammaglobulinemia (Low Levels of Immunoglobulins in the Blood)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00038
Issued / Original Publication Date: 2015-02-04
Summary Basis of Decision for Blincyto
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00207
Product Type: Drug
Control Number: 181723
DIN(s): 02450283
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-01-30
Issued / Original Publication Date: 2016-01-26
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-05-06
Summary Basis of Decision for Orkambi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00294
Product Type: Drug
Control Number: 181715
DIN(s): 02451379, 02463040, 02483831, 02483858, 02537087
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-01-30
Issued / Original Publication Date: 2016-03-29
Decision / Authorization Date: 2016-01-26
Updated Date: 2025-02-05
Summary Safety Review - DOMPERIDONE - Serious abnormal heart rhythms and sudden death (cardiac arrest)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00039
Issued / Original Publication Date: 2015-01-27
Summary Safety Review - PROLIA (denosumab) - Risk of Malignancy (Cancer)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00040
Issued / Original Publication Date: 2015-01-23
Summary Safety Review - Atypical Antipsychotics - Liver failure
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00041
Issued / Original Publication Date: 2015-01-22
Summary Safety Review - ARICEPT (donepezil) - Risk of Rhabdomyolysis and Neuroleptic Malignant Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00042
Issued / Original Publication Date: 2015-01-21
Summary Safety Review - Metoclopramide - Abnormal Involuntary Movements of the Body (Extrapyramidal Symptoms) in Children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00043
Issued / Original Publication Date: 2015-01-15

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