Review decisions

Showing 1930 results of 2627 total
Regulatory Decision Summary for Kevzara
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00205
Product Type: Drug
Control Number: 191745
DIN(s): 02460548
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-01-28
Decision / Authorization Date: 2017-01-12
Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00143
Issued / Original Publication Date: 2017-01-10
Regulatory Decision Summary for Fiasp
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00206
Product Type: Drug
Control Number: 191494
DIN(s): 02460408, 02460416, 02460424
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-01-20
Decision / Authorization Date: 2017-01-06
Regulatory Decision Summary for Ilaris
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00207
Product Type: Drug
Control Number: 195617
DIN(s): 02460351
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-05-30
Decision / Authorization Date: 2017-01-06
Summary Safety Review - KEPPRA (levetiracetam) - Assessing the Potential Risk of Acute Kidney Injury (Acute renal failure/Interstitial nephritis)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00142
Issued / Original Publication Date: 2017-01-06
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) - Assessing the Potential Risk of Autism
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00144
Issued / Original Publication Date: 2017-01-06
Summary Safety Review - Amiodarone (intravenous) - Assessing the potential risk of side effects in fetuses and newborns
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00145
Issued / Original Publication Date: 2017-01-06
Regulatory Decision Summary for Mictoryl, Mictoryl Pediatric
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00208
Product Type: Drug
Control Number: 188323
DIN(s): 02460262, 02460270, 02460289
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-10-23
Decision / Authorization Date: 2017-01-05
Regulatory Decision Summary for Rapivab
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00212
Product Type: Drug
Control Number: 191280
DIN(s): 02460319
Manufacturer: Biocryst Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-01-25
Decision / Authorization Date: 2017-01-05
Regulatory Decision Summary for Gazyva
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00204
Product Type: Drug
Control Number: 191269
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2016-01-11
Decision / Authorization Date: 2016-12-29

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