Review decisions
Showing 490 results of 1549 total
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/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/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/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
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
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01008
Product Type: Drug
Control Number: 261220
Manufacturer: Hoffmann-La Roche Ltd.
Submission Type: Supplement to a New Drug Submission (COVID-19)
Date Filed / Submission Date: 2022-02-04
Decision / Authorization Date: 2022-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01017
Product Type: Drug
Control Number: 242332
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-12-06
Decision / Authorization Date: 2022-10-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01011
Product Type: Drug
Control Number: 258126
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2021-10-29
Decision / Authorization Date: 2022-10-12