Review decisions
Showing 2150 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00072
Product Type: Drug
Control Number: 182788
DIN(s): 02452340
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-12
Decision / Authorization Date: 2016-02-22
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00110
Product Type: Drug
Control Number: 182613
Manufacturer: Bayer Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-03-03
Decision / Authorization Date: 2016-02-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00087
Issued / Original Publication Date: 2016-02-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00069
Product Type: Drug
Control Number: 180385
DIN(s): 02451816
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2014-12-23
Decision / Authorization Date: 2016-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00184
Product Type: Drug
Control Number: 182566
Manufacturer: GlaxoSmithKline Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2015-03-02
Decision / Authorization Date: 2016-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00347
Product Type: Drug
Control Number: 191745
DIN(s): 02460548, 02472961, 02472988
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2016-01-29
Issued / Original Publication Date: 2017-03-03
Decision / Authorization Date: 2017-01-12
Updated Date: 2023-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00089
Product Type: Drug
Control Number: 181693
DIN(s): 02451441, 02451468, 02451476, 02451484, 02451492
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-02-15
Decision / Authorization Date: 2016-01-27
Summary Safety Review - GALEXOS (simeprevir) - Assessing the Potential Risk of Severe Liver Problems
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00001
Issued / Original Publication Date: 2016-01-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00084
Product Type: Drug
Control Number: 180793
DIN(s): 02451336, 02451344, 02451352, 02451360
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2015-02-09
Decision / Authorization Date: 2016-01-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00097
Product Type: Drug
Control Number: 181715
DIN(s): 02451379
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-01-30
Decision / Authorization Date: 2016-01-26