Review decisions

Showing 2040 results of 2627 total
Summary Safety Review - YONDELIS (trabectedin) - Assessing the Potential Risk of Fluid Leakage from Small Blood Vessels (capillary leak syndrome)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00102
Issued / Original Publication Date: 2016-08-04
Regulatory Decision Summary for Synjardy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00211
Product Type: Drug
Control Number: 186812
DIN(s): 02456575, 02456583, 02456591, 02456605, 02456613, 02456621
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-08-17
Decision / Authorization Date: 2016-07-29
Summary Safety Review - Codeine-containing products - Further Assessing the Risk of Serious Breathing Problems in Children and Adolescents
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00096
Issued / Original Publication Date: 2016-07-28
Summary Safety Review - Hydrocodone-containing products - Assessing the Risk of Serious Breathing Problems (respiratory depression) in Children and Adolescents
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00100
Issued / Original Publication Date: 2016-07-28
Regulatory Decision Summary for JARDIANCE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00152
Product Type: Drug
Control Number: 190736
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-12-31
Decision / Authorization Date: 2016-07-27
Regulatory Decision Summary for BEPREVE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00154
Product Type: Drug
Control Number: 179294
DIN(s): 02456532
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-08-19
Decision / Authorization Date: 2016-07-27
Summary Safety Review - KOGENATE FS/HELIXATE FS (Antihemophilic Factor [Recombinant]) - Assessing the Potential Changes in the Known Risk of Inhibitors (Inhibitory Antibody - IA) Development in Previously Untreated Patients with Severe Hemophilia A
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00116
Issued / Original Publication Date: 2016-07-26
Regulatory Decision Summary for CINQAIR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00140
Product Type: Drug
Control Number: 185873
DIN(s): 02456419
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-07-03
Decision / Authorization Date: 2016-07-20
Regulatory Decision Summary for RUPATADINE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00162
Product Type: Drug
Control Number: 186488
DIN(s): 02456451, 02456478
Manufacturer: Pediapharm Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-08-04
Decision / Authorization Date: 2016-07-20
Regulatory Decision Summary for IMBRUVICA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00151
Product Type: Drug
Control Number: 190730
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2015-12-21
Decision / Authorization Date: 2016-07-19

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