Review decisions

Showing 2110 results of 2627 total
Regulatory Decision Summary for COSENTYX PSA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00074
Product Type: Drug
Control Number: 184142
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-04-30
Decision / Authorization Date: 2016-04-20
Summary Basis of Decision for Erelzi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00360
Product Type: Drug
Control Number: 193864
DIN(s): 02462850, 02462869, 02462877
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-04-18
Issued / Original Publication Date: 2017-08-03
Decision / Authorization Date: 2017-04-06
Updated Date: 2024-04-24
Regulatory Decision Summary for KEYTRUDA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00129
Product Type: Drug
Control Number: 186275
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-07-16
Decision / Authorization Date: 2016-04-15
Summary Basis of Decision for Xtoro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00314
Product Type: Drug
Control Number: 172450
DIN(s): 02452928
Manufacturer: Alcon Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-04-13
Updated Date: 2019-03-22
Regulatory Decision Summary for XIGDUO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00113
Product Type: Drug
Control Number: 191680
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-01-27
Decision / Authorization Date: 2016-04-12
Regulatory Decision Summary for HOLKIRA PAK
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00168
Product Type: Drug
Control Number: 184061
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-05-01
Decision / Authorization Date: 2016-04-11
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

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