Review decisions

Showing 1770 results of 2627 total
Summary Safety Review - Paradigm insulin infusion pump - Assessing the potential risk of malfunctions with the device
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00175
Issued / Original Publication Date: 2017-10-23
Regulatory Decision Summary for Plivensia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00311
Product Type: Drug
Control Number: 205568
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-05-11
Decision / Authorization Date: 2017-10-19
Summary Basis of Decision for Vosevi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00367
Product Type: Drug
Control Number: 202324
DIN(s): 02467542
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2017-10-17
Updated Date: 2022-11-07
Summary Basis of Decision for Alunbrig
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00415
Product Type: Drug
Control Number: 210369
DIN(s): 02479206, 02479214, 02479222, 02479230
Manufacturer: Takeda Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2017-10-17
Issued / Original Publication Date: 2019-01-28
Decision / Authorization Date: 2018-07-26
Updated Date: 2025-02-05
Regulatory Decision Summary for Shingrix
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00293
Product Type: Drug
Control Number: 200244
DIN(s): 02468425
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-11-14
Decision / Authorization Date: 2017-10-13
Regulatory Decision Summary for Accel-sevelamer
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00328
Product Type: Drug
Control Number: 189932
DIN(s): 02461501
Manufacturer: Accel Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-02-24
Decision / Authorization Date: 2017-10-11
Regulatory Decision Summary for Auro-Cefixime
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00339
Product Type: Drug
Control Number: 189720
DIN(s): 02468689
Manufacturer: Auro Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-12-02
Decision / Authorization Date: 2017-10-11
Regulatory Decision Summary for I-Factor Flex FR
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00407
Product Type: Drug
Manufacturer: Cerapedics, Inc.
Date Filed / Submission Date: 2016-12-02
Decision / Authorization Date: 2017-10-11
Regulatory Decision Summary for Triumeq
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00443
Product Type: Drug
Control Number: 208070
Manufacturer: ViiV Healthcare ULC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2017-07-31
Decision / Authorization Date: 2017-10-11
Regulatory Decision Summary for Trumenba
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00296
Product Type: Drug
Control Number: 195550
DIN(s): 02468751
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2016-05-31
Decision / Authorization Date: 2017-10-05

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