Review decisions

Showing 2310 results of 2632 total
Regulatory Decision Summary for Duaklir Genuair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00015
Product Type: Drug
Control Number: 172711
DIN(s): 02439530
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-03-03
Decision / Authorization Date: 2015-04-02
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 Brivlera
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00284
Product Type: Drug
Control Number: 183355
DIN(s): 02452936, 02452944, 02452952, 02452960, 02452979, 02452987, 02452995
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-30
Issued / Original Publication Date: 2016-07-05
Decision / Authorization Date: 2016-03-09
Updated Date: 2025-08-26
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, 02547732
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: 2025-08-07
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 Basis of Decision for Cerdelga
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00359
Product Type: Drug
Control Number: 183050
DIN(s): 02463261
Manufacturer: Sanofi Genzyme, A Division of Sanofi-aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-19
Issued / Original Publication Date: 2017-07-10
Decision / Authorization Date: 2017-04-21
Updated Date: 2025-02-12
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: 2025-07-31

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