Review decisions

Showing 70 results of 2190 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702485830271
Product Type: Drug
Control Number: 270800
Manufacturer: Emergent Product Development Gaithersburg Inc.
Submission Type: Extraordinary Use New Drug Submission
Date Filed / Submission Date: 2022-12-20
Decision / Authorization Date: 2023-12-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704223637070
Product Type: Drug
Control Number: 273519
DIN(s): 02543559, 02543567
Manufacturer: Pfizer Canada ULC
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-03-21
Decision / Authorization Date: 2023-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1702069947544
Product Type: Drug
Control Number: 268590
DIN(s): 02324032, 02371081
Manufacturer: Merz Pharmaceuticals GmbH / Merz Pharma Canada Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-10-07
Decision / Authorization Date: 2023-10-06
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/RDS1710783226359
Product Type: Drug
Control Number: 273741
DIN(s): 02542641, 02542676, 02542684, 02542692
Manufacturer: Medison Pharma Canada Inc.
Submission Type: New Drug Submission – Priority Review
Date Filed / Submission Date: 2023-04-05
Decision / Authorization Date: 2023-10-23
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