Review decisions

Showing 2230 results of 2627 total
Regulatory Decision Summary for Abilify Maintena
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00002
Product Type: Drug
Control Number: 178110
Manufacturer: Otsuka Pharmaceutical Co. Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-09-30
Decision / Authorization Date: 2015-09-16
Summary Safety Review - GILENYA (fingolimod) - Assessing the Risk of the Abnormal Tissue Growth (Cancer)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00016
Issued / Original Publication Date: 2015-09-14
Summary Basis of Decision for Darzalex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00321
Product Type: Drug
Control Number: 187648
DIN(s): 02455951, 02455978, 02502712
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-09-14
Issued / Original Publication Date: 2016-09-08
Decision / Authorization Date: 2016-06-29
Updated Date: 2025-05-21
Regulatory Decision Summary for REPATHA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00043
Product Type: Drug
Control Number: 178234
DIN(s): 02446057
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-09-19
Decision / Authorization Date: 2015-09-10
Summary Safety Review - REVOLADE (eltrombopag) - Serious Skin Reactions
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00017
Issued / Original Publication Date: 2015-09-10
Regulatory Decision Summary for Intuniv XR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00028
Product Type: Drug
Control Number: 178245
Manufacturer: Shire Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-09-23
Decision / Authorization Date: 2015-09-08
Regulatory Decision Summary for REVESTIVE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00044
Product Type: Drug
Control Number: 180223
DIN(s): 02445727
Manufacturer: NPS Pharma Holdings Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2014-12-01
Decision / Authorization Date: 2015-09-04
Summary Safety Review - Bortezomib (VELCADE and Generics) - Assessing a Potential Link with Flesh-Eating Disease (Necrotising Fasciitis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00018
Issued / Original Publication Date: 2015-09-03
Summary Basis of Decision for Lixiana
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00338
Product Type: Drug
Control Number: 187363
DIN(s): 02458640, 02458659, 02458667
Manufacturer: Daiichi Sankyo, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-09-03
Issued / Original Publication Date: 2016-12-21
Decision / Authorization Date: 2016-11-04
Updated Date: 2026-03-09
Regulatory Decision Summary for Basaglar
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00009
Product Type: Drug
Control Number: 177405
DIN(s): 02444844, 02444852
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-08-29
Decision / Authorization Date: 2015-09-01

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