Review decisions

Showing 2180 results of 2606 total
Summary Basis of Decision for Alecensaro
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00332
Product Type: Drug
Control Number: 189442
DIN(s): 02458136
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-11-12
Issued / Original Publication Date: 2016-10-31
Decision / Authorization Date: 2016-09-29
Updated Date: 2026-02-09
Regulatory Decision Summary for TRULICITY
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00054
Product Type: Drug
Control Number: 168671
DIN(s): 02448572, 02448580, 02448599, 02448602
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-02-10
Decision / Authorization Date: 2015-11-10
Regulatory Decision Summary for Humira
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00004
Product Type: Drug
Control Number: 180556
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-12-11
Decision / Authorization Date: 2015-11-05
Summary Safety Review - ABILIFY and ABILIFY MAINTENA (aripiprazole) - Evaluating the Risk of Certain Impulse Control Behaviours
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00011
Issued / Original Publication Date: 2015-11-02
Regulatory Decision Summary for BYDUREON
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00071
Product Type: Drug
Control Number: 167695
DIN(s): 02448610
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-12-17
Decision / Authorization Date: 2015-10-30
Summary Basis of Decision for Daklinza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00180
Product Type: Drug
Control Number: 172616
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-10-27
Updated Date: 2020-10-13
Summary Safety Review - Strontium - Risk of Heart and Circulatory Side Effects
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00012
Issued / Original Publication Date: 2015-10-22
Regulatory Decision Summary for Technivie
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00052
Product Type: Drug
Control Number: 183275
DIN(s): 02447711
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-03-26
Decision / Authorization Date: 2015-10-20
Regulatory Decision Summary for Xgeva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00059
Product Type: Drug
Control Number: 176891
Manufacturer: Amgen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-07-31
Decision / Authorization Date: 2015-10-19
Summary Safety Review - Sodium Glucose Cotransporter 2 (SGLT2) Inhibitors INVOKANA (canagliflozin) and FORXIGA (dapagliflozin) - Evaluation of a Potential Risk of Acute Kidney Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00062
Issued / Original Publication Date: 2015-10-16

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