Review decisions
Showing 60 results of 1257 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1703188857510
Product Type: Drug
Control Number: 264439
DIN(s): 02470365, 02492504, 02510049, 02524252
Manufacturer: Sanofi-Aventis Canada Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-20
Decision / Authorization Date: 2023-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1704984251239
Product Type: Drug
Control Number: 271030
DIN(s): 02539888
Manufacturer: Mirum Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2022-12-28
Decision / Authorization Date: 2023-07-21
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706106900025
Product Type: Drug
Control Number: 270698
DIN(s): 02478374, 02540185
Manufacturer: Janssen Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-12-15
Decision / Authorization Date: 2023-08-02
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1706285264505
Product Type: Drug
Control Number: 270386
DIN(s): 02409623, 02409658, 02539993
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2022-12-05
Decision / Authorization Date: 2023-07-24
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