Review decisions

Showing 2000 results of 2304 total
Regulatory Decision Summary for ICLUSIG
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00083
Product Type: Drug
Control Number: 165121
DIN(s): 02437333, 02437341
Manufacturer: ARIAD Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-05-23
Decision / Authorization Date: 2015-04-02
Summary Safety Review - Methylphenidate - Suicidal Thoughts and Behaviour (Suicidality)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00033
Issued / Original Publication Date: 2015-03-30
Summary Safety Review - Amphetamines - Suicidal Thoughts and Behaviours (Suicidality)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00034
Issued / Original Publication Date: 2015-03-30
Summary Basis of Decision for Praluent
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00277
Product Type: Drug
Control Number: 183116
DIN(s): 02453754, 02453762, 02453819, 02453835
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-20
Issued / Original Publication Date: 2016-06-08
Decision / Authorization Date: 2016-04-11
Updated Date: 2023-12-04
Summary Basis of Decision for Holkira Pak
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00250
Product Type: Drug
Control Number: 174739
DIN(s): 02436027
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-03-19
Updated Date: 2020-10-08
Summary Safety Review - Tumour necrosis factor (TNF) blockers - Glioblastoma (brain tumour)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00035
Issued / Original Publication Date: 2015-03-18
Summary Basis of Decision for Lynparza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00292
Product Type: Drug
Control Number: 182823
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Issued / Original Publication Date: 2016-07-12
Decision / Authorization Date: 2016-04-29
Updated Date: 2024-01-03
Summary Basis of Decision for Uptravi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00326
Product Type: Drug
Control Number: 182114
DIN(s): 02451158, 02451166, 02451174, 02451182, 02451190, 02451204, 02451212, 02451220
Manufacturer: Actelion Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-13
Issued / Original Publication Date: 2016-03-03
Decision / Authorization Date: 2016-01-20
Updated Date: 2024-03-01
Summary Safety Review - ZELBORAF (vemurafenib) - Pancreatitis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00036
Issued / Original Publication Date: 2015-02-12
Summary Safety Review - PRADAXA (dabigatran) and MULTAQ (dronedarone) or CORDARONE (amiodarone) - Drug-Drug Interaction
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00037
Issued / Original Publication Date: 2015-02-12

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