Review decisions

Showing 90 results of 2223 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710787451238
Product Type: Drug
Control Number: 268527
DIN(s): 02172739, 02172747, 02172755
Manufacturer: GE Healthcare Canada Inc.
Submission Type: Supplemental New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2023-12-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710791169293
Product Type: Drug
Control Number: 268723
DIN(s): 02543532
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-19
Decision / Authorization Date: 2023-11-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701460825795
Product Type: Drug
Control Number: 278519
Manufacturer: Novavax Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2023-08-31
Decision / Authorization Date: 2023-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1701354245768
Product Type: Drug
Control Number: 267444
DIN(s): 02542714
Manufacturer: Sanofi Pasteur Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-29
Decision / Authorization Date: 2023-10-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1700599569568
Product Type: Drug
Control Number: 274515
DIN(s): 02523434
Manufacturer: GlaxoSmithKline Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-19
Decision / Authorization Date: 2023-11-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702060641808
Product Type: Drug
Control Number: 268742
DIN(s): 02543036, 02543044
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-01
Decision / Authorization Date: 2023-11-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1707229586312
Product Type: Drug
Control Number: 268282
DIN(s): 02542943
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-09-29
Decision / Authorization Date: 2023-11-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1698933880208
Product Type: Drug
Control Number: 268334
DIN(s): 02401347
Manufacturer: Seagen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-03
Decision / Authorization Date: 2023-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699385708073
Product Type: Drug
Control Number: 273721
DIN(s): 02542560
Manufacturer: CSL Behring Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2023-03-27
Decision / Authorization Date: 2023-10-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1699548065621
Product Type: Drug
Control Number: 269852
DIN(s): 02491559, 02533448, 02533456
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-11-17
Decision / Authorization Date: 2023-10-30