Review decisions

Showing 1960 results of 2304 total
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
Regulatory Decision Summary for Kalydeco
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00030
Product Type: Drug
Control Number: 179589
DIN(s): 02442612, 02442620
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2014-11-14
Decision / Authorization Date: 2015-06-12
Regulatory Decision Summary for OTEZLA
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00098
Product Type: Drug
Control Number: 164228
Manufacturer: Celgene Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2013-04-19
Decision / Authorization Date: 2015-06-10
Summary Basis of Decision for Ferriprox
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00215
Product Type: Drug
Control Number: 162924
DIN(s): 02436523, 02436531, 02436558
Manufacturer: ApoPharma Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-06-10
Updated Date: 2019-04-24
Summary Basis of Decision for Brenzys
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00333
Product Type: Drug
Control Number: 184793
DIN(s): 02455323, 02455331
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-06-08
Issued / Original Publication Date: 2016-11-03
Decision / Authorization Date: 2016-08-31
Updated Date: 2023-02-16
Summary Basis of Decision for Carbaglu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00176
Product Type: Drug
Control Number: 171358
DIN(s): 02439360
Manufacturer: Orphan Europe S.A.R.L.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-06-08
Updated Date: 2020-09-24

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