Review decisions

Showing 2120 results of 2631 total
Regulatory Decision Summary for PRALUENT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00099
Product Type: Drug
Control Number: 183116
DIN(s): 02453754, 02453762, 02453819, 02453835
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-03-20
Decision / Authorization Date: 2016-04-11
Summary Safety Review - Celecoxib (CELEBREX and generics) - Assessing the Risk of Serious Heart and Stroke Side Effects at High Doses Relative to Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00073
Issued / Original Publication Date: 2016-04-11
Regulatory Decision Summary for ADREVIEW
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00065
Product Type: Drug
Control Number: 171024
Manufacturer: GE Healthcare Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2013-12-23
Decision / Authorization Date: 2016-04-07
Regulatory Decision Summary for VITAMIN A (100,000 IU ) and VITAMIN E (20 IU ) ORAL LIQUID PREPARATION
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00111
Product Type: Drug
Control Number: 167923
DIN(s): 02453584
Manufacturer: Nutricorp International
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-09-13
Decision / Authorization Date: 2016-04-06
Regulatory Decision Summary for VITAMIN A (200,000 IU) and VITAMIN E (40 IU) ORAL LIQUID PREPARATION
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00112
Product Type: Drug
Control Number: 167924
DIN(s): 02453592
Manufacturer: Nutricorp International
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-09-13
Decision / Authorization Date: 2016-04-06
Summary Basis of Decision for Nitisinone Tablets
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00345
Product Type: Drug
Control Number: 193770
DIN(s): 02458616, 02458624, 02458632
Manufacturer: Cycle Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-04-05
Issued / Original Publication Date: 2017-02-17
Decision / Authorization Date: 2016-11-04
Updated Date: 2025-07-30
Summary Safety Review - PERJETA (pertuzumab) - Assessing the Potential Risk of Stevens-Johnson Syndrome
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00075
Issued / Original Publication Date: 2016-04-04
Summary Safety Review - ULORIC (febuxostat) - Assessing the Potential Risk of Heart Failure
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00077
Issued / Original Publication Date: 2016-04-01
Summary Basis of Decision for Ozanex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00358
Product Type: Drug
Control Number: 192925
DIN(s): 02463504
Manufacturer: Ferrer Internacional, S.A.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-04-01
Issued / Original Publication Date: 2017-06-21
Decision / Authorization Date: 2017-05-01
Updated Date: 2025-08-27
Regulatory Decision Summary for IMBRUVICA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00085
Product Type: Drug
Control Number: 183766
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-04-16
Decision / Authorization Date: 2016-03-31

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