Review decisions

Showing 600 results of 820 total
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
Summary Basis of Decision for Rosiver
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00268
Product Type: Drug
Control Number: 172733
DIN(s): 02440342
Manufacturer: Galderma Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-06-04
Updated Date: 2021-11-18
Regulatory Decision Summary for INSPIOLTO RESPIMAT
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00027
Product Type: Drug
Control Number: 173315
DIN(s): 02441888
Manufacturer: Boehringer Ingelheim Canada Ltd./Ltée.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-09
Decision / Authorization Date: 2015-06-01
Regulatory Decision Summary for TOUJEO SoloSTAR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00053
Product Type: Drug
Control Number: 173316
DIN(s): 02441829
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-06-13
Decision / Authorization Date: 2015-05-28
Summary Basis of Decision for Prolensa
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00265
Product Type: Drug
Control Number: 171657
DIN(s): 02439123
Manufacturer: Bausch and Lomb, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-05-12
Updated Date: 2019-04-02
Regulatory Decision Summary for SmofKabiven
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00047
Product Type: Drug
Control Number: 174522
DIN(s): 02440695
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2014-05-14
Decision / Authorization Date: 2015-05-06
Summary Basis of Decision for Pheburane
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00261
Product Type: Drug
Control Number: 175573
DIN(s): 02436663
Manufacturer: Medunik Canada
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-05-01
Updated Date: 2019-01-04

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