Review decisions

Showing 1500 results of 2627 total
Regulatory Decision Summary for Orkambi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00602
Product Type: Drug
Control Number: 215032
DIN(s): 02483831, 02483858
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-04-04
Decision / Authorization Date: 2018-12-11
Regulatory Decision Summary for Bosulif
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00487
Product Type: Drug
Control Number: 211317
DIN(s): 02483793
Manufacturer: Pfizer Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-11-28
Decision / Authorization Date: 2018-12-10
Regulatory Decision Summary for Crysvita
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00463
Product Type: Drug
Control Number: 216239
DIN(s): 02483629, 02483637, 02483645
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission - Priority Review
Date Filed / Submission Date: 2018-05-16
Decision / Authorization Date: 2018-12-05
Summary Safety Review - Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs) - Assessing the potential risk of abnormal structural changes of the artery walls including rupture (Artery Dissections and Artery Aneurysms)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00213
Issued / Original Publication Date: 2018-12-03
Regulatory Decision Summary for Humira
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00494
Product Type: Drug
Control Number: 212133
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-12-20
Decision / Authorization Date: 2018-11-30
Regulatory Decision Summary for Belsomra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00475
Product Type: Drug
Control Number: 196367
DIN(s): 02483505
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-07-05
Decision / Authorization Date: 2018-11-29
Regulatory Decision Summary for Acetaminophen Injection
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00565
Product Type: Drug
Control Number: 209478
DIN(s): 02483343
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-09-20
Decision / Authorization Date: 2018-11-29
Regulatory Decision Summary for Unituxin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00458
Product Type: Drug
Control Number: 212066
DIN(s): 02483076
Manufacturer: United Therapeutics Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2017-12-14
Decision / Authorization Date: 2018-11-28
Regulatory Decision Summary for Darzalex
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00476
Product Type: Drug
Control Number: 212559
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2018-01-03
Decision / Authorization Date: 2018-11-27
Summary Safety Review - Sunscreen products - Assessing the potential risk of skin reactions
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00211
Issued / Original Publication Date: 2018-11-26
Updated Date: 2020-06-26

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