Review decisions

Showing 2160 results of 2627 total
Summary Basis of Decision for Genvoya
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00286
Product Type: Drug
Control Number: 181399
DIN(s): 02449498
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-01-26
Updated Date: 2021-11-12
Summary Basis of Decision for Procysbi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00362
Product Type: Drug
Control Number: 191347
DIN(s): 02464705, 02464713
Manufacturer: Horizon Pharma Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2016-01-21
Issued / Original Publication Date: 2017-08-21
Decision / Authorization Date: 2017-06-13
Updated Date: 2025-07-02
Regulatory Decision Summary for UPTRAVI
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00108
Product Type: Drug
Control Number: 182114
DIN(s): 02451158, 02451166, 02451174, 02451182, 02451190, 02451204, 02451212, 02451220
Manufacturer: Actelion Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-13
Decision / Authorization Date: 2016-01-20
Regulatory Decision Summary for ZEPATIER
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00173
Product Type: Drug
Control Number: 185866
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-06-30
Decision / Authorization Date: 2016-01-19
Regulatory Decision Summary for KYPROLIS
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00119
Product Type: Drug
Control Number: 184479
DIN(s): 02451034
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-05-19
Decision / Authorization Date: 2016-01-15
Regulatory Decision Summary for VIACORAM
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00109
Product Type: Drug
Control Number: 180798
DIN(s): 02451530, 02451549, 02451557
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-12-18
Decision / Authorization Date: 2016-01-08
Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00002
Issued / Original Publication Date: 2016-01-08
Regulatory Decision Summary for NATESTO
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00122
Product Type: Drug
Control Number: 181379
DIN(s): 02450550
Manufacturer: Acerus Pharmaceuticals Srl
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-01-23
Decision / Authorization Date: 2016-01-05
Regulatory Decision Summary for HUMIRA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00025
Product Type: Drug
Control Number: 181320
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-01-15
Decision / Authorization Date: 2015-12-31
Summary Safety Review - AVONEX (interferon beta-1a) - Assessing the Potential Risk of Kidney Damage (nephrotic syndrome)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00003
Issued / Original Publication Date: 2015-12-23

Displaying 2151 - 2160 of 2627 | Page 216 of 263
Date modified: