Review decisions

Showing 2020 results of 2627 total
Summary Basis of Decision for Bepreve
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00324
Product Type: Drug
Control Number: 179294
DIN(s): 02456532
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2016-09-07
Updated Date: 2017-06-06
Summary Safety Review - Viscous Lidocaine 2% - Assessing the Potential Risk of Severe Side Effects in Infants and Young Children
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00105
Issued / Original Publication Date: 2016-08-29
Summary Safety Review - Bortezomib (VELCADE and generics) - Assessing the Potential Risk of Flesh-Eating Disease (Necrotizing Fasciitis) - UPDATE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00106
Issued / Original Publication Date: 2016-08-26
Regulatory Decision Summary for GIOTRIF
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00161
Product Type: Drug
Control Number: 187656
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-09-14
Decision / Authorization Date: 2016-08-25
Summary Safety Review - Lanoxin, Toloxin, Apo-digoxin, PMS-digoxin, (Digoxin) - Assessing the Potential Higher Risk of Death Compared to Patients not Using Digoxin
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00107
Issued / Original Publication Date: 2016-08-23
Regulatory Decision Summary for WILATE
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00156
Product Type: Drug
Control Number: 188627
Manufacturer: Octapharma Pharmazeutika Produktionsges m.b.H.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-28
Decision / Authorization Date: 2016-08-19
Regulatory Decision Summary for GENTAMICIN INJECTION USP
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00157
Product Type: Drug
Control Number: 183885
DIN(s): 02457008
Manufacturer: Teligent OÜ
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-09-17
Decision / Authorization Date: 2016-08-19
Summary Safety Review - GILENYA (fingolimod) - Assessing the Potential Risk of a Rare Brain Infection (Progressive Multifocal Leukoencephalopathy)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00108
Issued / Original Publication Date: 2016-08-19
Summary Basis of Decision for Evenity
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00451
Product Type: Drug
Control Number: 197713
DIN(s): 02489597
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-08-18
Issued / Original Publication Date: 2019-11-21
Decision / Authorization Date: 2019-06-17
Updated Date: 2025-07-31
Regulatory Decision Summary for ALPROLIX
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00147
Product Type: Drug
Control Number: 188247
Manufacturer: Biogen Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-10-19
Decision / Authorization Date: 2016-08-16

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