Review decisions
Showing 340 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00450
Product Type: Drug
Control Number: 216792
DIN(s): 02489783, 02530031
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-06-04
Issued / Original Publication Date: 2019-11-19
Decision / Authorization Date: 2019-06-27
Updated Date: 2025-08-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00430
Product Type: Drug
Control Number: 216539
DIN(s): 02484013
Manufacturer: BioMarin International Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-05-25
Issued / Original Publication Date: 2019-05-09
Decision / Authorization Date: 2018-12-19
Updated Date: 2025-08-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00429
Product Type: Drug
Control Number: 216239
DIN(s): 02483629, 02483637, 02483645
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-05-16
Issued / Original Publication Date: 2019-05-06
Decision / Authorization Date: 2018-12-05
Updated Date: 2026-03-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00444
Product Type: Drug
Control Number: 215753
DIN(s): 02487454, 02519283, 02519291, 02532093, 02532107, 02546922, 02552507
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-05-07
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-17
Updated Date: 2025-08-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00438
Product Type: Drug
Control Number: 215733
DIN(s): 02485966, 02485974
Manufacturer: Pfizer Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-04-26
Issued / Original Publication Date: 2019-07-18
Decision / Authorization Date: 2019-02-22
Updated Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00445
Product Type: Drug
Control Number: 215268
DIN(s): 02487098, 02487101, 02487128, 02487136
Manufacturer: Eli Lilly Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2019-09-26
Decision / Authorization Date: 2019-04-05
Updated Date: 2024-11-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00470
Product Type: Drug
Control Number: 215409
DIN(s): 02495589
Manufacturer: Avir Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2018-04-16
Issued / Original Publication Date: 2020-04-24
Decision / Authorization Date: 2020-01-13
Updated Date: 2025-03-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00447
Product Type: Drug
Control Number: 214572
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2018-03-16
Issued / Original Publication Date: 2019-10-22
Decision / Authorization Date: 2019-02-26
Updated Date: 2025-02-19
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00457
Product Type: Drug
Control Number: 214504
DIN(s): 02491788, 02535696
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2018-03-15
Issued / Original Publication Date: 2020-01-13
Decision / Authorization Date: 2019-08-23
Updated Date: 2025-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00417
Product Type: Drug
Control Number: 214391
DIN(s): 02475472
Manufacturer: Mitsubishi Tanabe Pharma Corporation
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2018-03-09
Issued / Original Publication Date: 2019-02-07
Decision / Authorization Date: 2018-10-03
Updated Date: 2025-07-08