Review decisions

Showing 2270 results of 2632 total
Regulatory Decision Summary for EPERZAN
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00017
Product Type: Drug
Control Number: 165145
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-05-23
Decision / Authorization Date: 2015-07-15
Regulatory Decision Summary for Vibativ
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00005
Product Type: Drug
Control Number: 176895
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-08-01
Decision / Authorization Date: 2015-07-14
Summary Safety Review - Acetaminophen - Liver Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00120
Issued / Original Publication Date: 2015-07-09
Summary Basis of Decision for Cinqair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00331
Product Type: Drug
Control Number: 185873
DIN(s): 02456419
Manufacturer: Teva Canada Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-07-03
Issued / Original Publication Date: 2016-10-25
Decision / Authorization Date: 2016-07-20
Updated Date: 2024-02-09
Summary Safety Review - FERAHEME (ferumoxytol) - Serious allergic reactions (Hypersensitivity reactions)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00023
Issued / Original Publication Date: 2015-07-03
Regulatory Decision Summary for Quinsair
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00042
Product Type: Drug
Control Number: 171934
DIN(s): 02442302
Manufacturer: Tripex Pharmaceuticals Llc
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-02-13
Decision / Authorization Date: 2015-06-29
Summary Safety Review - TECFIDERA (Dimethyl Fumarate) - Serious allergic reactions including skin reactions and anaphylaxis
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00024
Issued / Original Publication Date: 2015-06-26
Regulatory Decision Summary for Ofev
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00034
Product Type: Drug
Control Number: 176043
DIN(s): 02443066, 02443074
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-07-09
Decision / Authorization Date: 2015-06-25
Regulatory Decision Summary for Yasmin Plus
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00061
Product Type: Drug
Control Number: 149696
DIN(s): 02442744
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-30
Decision / Authorization Date: 2015-06-18
Summary Safety Review - Intravenous Methylprednisolone - Liver Injury
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00025
Issued / Original Publication Date: 2015-06-18

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