Review decisions

Showing 480 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00292
Product Type: Drug
Control Number: 182823
DIN(s): 02475200, 02475219
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-03-16
Issued / Original Publication Date: 2016-07-12
Decision / Authorization Date: 2016-04-29
Updated Date: 2025-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00278
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
Issued / Original Publication Date: 2016-03-30
Decision / Authorization Date: 2016-02-22
Updated Date: 2025-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00208
Product Type: Drug
Control Number: 182734
DIN(s): 02446928, 02446936, 02446944
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-03-06
Issued / Original Publication Date: 2015-12-24
Decision / Authorization Date: 2015-10-02
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00326
Product Type: Drug
Control Number: 182114
DIN(s): 02451158, 02451166, 02451174, 02451182, 02451190, 02451204, 02451212, 02451220
Manufacturer: Actelion Pharmaceuticals Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-13
Issued / Original Publication Date: 2016-03-03
Decision / Authorization Date: 2016-01-20
Updated Date: 2024-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00287
Product Type: Drug
Control Number: 182048
DIN(s): 02453150, 02453169, 02453177, 02493535, 02493543, 02493551
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-02-12
Issued / Original Publication Date: 2016-05-19
Decision / Authorization Date: 2016-03-16
Updated Date: 2025-05-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00288
Product Type: Drug
Control Number: 180793
DIN(s): 02451336, 02451344, 02451352, 02451360, 02489627
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-02-09
Issued / Original Publication Date: 2016-03-09
Decision / Authorization Date: 2016-01-26
Updated Date: 2025-03-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00207
Product Type: Drug
Control Number: 181723
DIN(s): 02450283
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2015-01-30
Issued / Original Publication Date: 2016-01-26
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00294
Product Type: Drug
Control Number: 181715
DIN(s): 02451379, 02463040, 02483831, 02483858, 02537087
Manufacturer: Vertex Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2015-01-30
Issued / Original Publication Date: 2016-03-29
Decision / Authorization Date: 2016-01-26
Updated Date: 2025-02-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00249
Product Type: Drug
Control Number: 173180
DIN(s): 02432226
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2015-01-12
Updated Date: 2022-10-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00209
Product Type: Drug
Control Number: 180877
DIN(s): 02450291, 02450305, 02450313, 02450321, 02468220, 02468239, 02484056, 02484129
Manufacturer: Eisai Ltd.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2015-01-08
Issued / Original Publication Date: 2016-02-09
Decision / Authorization Date: 2015-12-22
Updated Date: 2025-03-03