Review decisions
Showing 360 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1747331021171
Product Type: Drug
Control Number: 285129
DIN(s): 02555948
Manufacturer: Ferring Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-20
Issued / Original Publication Date: 2025-05-11
Decision / Authorization Date: 2025-03-05
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1748529563500
Product Type: Drug
Control Number: 285014
DIN(s): 02555964, 02555972
Manufacturer: Janssen Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-15
Issued / Original Publication Date: 2025-05-28
Decision / Authorization Date: 2025-03-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710769045419
Product Type: Drug
Control Number: 267788
DIN(s): 02545764
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-03-01
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740501914989
Product Type: Drug
Control Number: 285051
Manufacturer: Acadia Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-15
Issued / Original Publication Date: 2025-02-21
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1769005259208
Product Type: Drug
Control Number: 284892
DIN(s): 02562081, 02562103, 02562111
Manufacturer: Biosimilar Collaborations Ireland Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-03-12
Issued / Original Publication Date: 2026-01-19
Decision / Authorization Date: 2025-10-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722024187528
Product Type: Drug
Control Number: 272694
DIN(s): 02461749, 02461757, 02461765, 02461773, 02461781, 02461803
Manufacturer: Otsuka Pharmaceutical Co Ltd.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-02-24
Decision / Authorization Date: 2024-01-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710165579186
Product Type: Drug
Control Number: 271806
DIN(s): 02545411
Manufacturer: Sandoz Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-27
Decision / Authorization Date: 2024-02-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749560194716
Product Type: Drug
Control Number: 284815
DIN(s): 02556898
Manufacturer: Amicus Therapeutics Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-08
Issued / Original Publication Date: 2025-06-09
Decision / Authorization Date: 2025-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1765981684341
Product Type: Drug
Control Number: 283028
DIN(s): 02562022, 02562030, 02562049, 02562057, 02562065
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-03-08
Issued / Original Publication Date: 2025-12-16
Decision / Authorization Date: 2025-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1743686266671
Product Type: Drug
Control Number: 284667
DIN(s): 02554429, 02554437
Manufacturer: Xediton Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-03-05
Issued / Original Publication Date: 2025-04-02
Decision / Authorization Date: 2025-01-17