Review decisions
Showing 340 results of 2299 total
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
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/SBD00611
Product Type: Drug
Control Number: 251277
DIN(s): 02527715
Manufacturer: Kyowa Kirin, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-10-25
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/SBD00610
Product Type: Drug
Control Number: 252301
DIN(s): 02527693
Manufacturer: BioCryst Pharmaceuticals, Inc.
Submission Type: New Drug Submission
Issued / Original Publication Date: 2022-10-19
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01009
Product Type: Drug
Control Number: 265382
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-06-22
Decision / Authorization Date: 2022-10-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01041
Product Type: Drug
Control Number: 256308
DIN(s): 02488078, 02488086, 02488094
Manufacturer: Verity Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-09-03
Decision / Authorization Date: 2022-10-18