Review decisions
Showing 650 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1708102173051
Product Type: Drug
Control Number: 269372
DIN(s): 02542137
Manufacturer: Sumitomo Pharma Switzerland GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2024-02-16
Decision / Authorization Date: 2023-10-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1695926847771
Product Type: Drug
Control Number: 258231
DIN(s): 02531917, 02531925
Manufacturer: Bayer Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-11-01
Decision / Authorization Date: 2022-10-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1686249847840
Product Type: Drug
Control Number: 269388
DIN(s): 02537206, 02537214
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-11-03
Issued / Original Publication Date: 2023-06-07
Decision / Authorization Date: 2023-04-19
Updated Date: 2024-12-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01044
Product Type: Drug
Control Number: 262999
DIN(s): 02532468, 02532476
Manufacturer: Gilead Sciences Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-04-06
Decision / Authorization Date: 2022-11-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1695302358644
Product Type: Drug
Control Number: 269369
DIN(s): 02539756, 02539764
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2022-11-02
Issued / Original Publication Date: 2023-09-20
Decision / Authorization Date: 2023-07-26
Updated Date: 2025-05-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1712065211631
Product Type: Drug
Control Number: 267923
DIN(s): 02542420
Manufacturer: Alnylam Netherlands B.v.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-31
Issued / Original Publication Date: 2024-03-28
Decision / Authorization Date: 2023-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01031
Product Type: Drug
Control Number: 243026
DIN(s): 02532247, 02532255, 02532263, 02532271, 02532298, 02532301, 02532328
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2021-10-27
Decision / Authorization Date: 2022-10-26
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1701180125532
Product Type: Drug
Control Number: 269021
DIN(s): 02540207
Manufacturer: GlaxoSmithKline Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2022-10-25
Issued / Original Publication Date: 2023-11-18
Decision / Authorization Date: 2023-08-04
Updated Date: 2024-06-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01012
Product Type: Drug
Control Number: 266189
DIN(s): 02532018
Manufacturer: Pfizer Canada ULC., on behalf of BioNTech Manufacturing GmbH
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2022-07-22
Decision / Authorization Date: 2022-10-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01023
Product Type: Drug
Control Number: 258394
DIN(s): 02532093, 02532107
Manufacturer: AbbVie Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-11-05
Decision / Authorization Date: 2022-10-19