Review decisions
Showing 40 results of 768 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1770920726931
Product Type: Drug
Control Number: 286523
Manufacturer: Polpharma Biologics S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-05-01
Issued / Original Publication Date: 2026-02-11
Decision / Authorization Date: 2025-09-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1760535633085
Product Type: Drug
Control Number: 285622
DIN(s): 02559056
Manufacturer: Amivas Ireland Ltd.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-04-03
Issued / Original Publication Date: 2025-10-10
Decision / Authorization Date: 2025-07-04
Updated Date: 2025-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1751980281334
Product Type: Drug
Control Number: 285444
DIN(s): 02558262
Manufacturer: Hoffmann-La Roche Limited
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-28
Issued / Original Publication Date: 2025-07-07
Decision / Authorization Date: 2025-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1752084831051
Product Type: Drug
Control Number: 285296
DIN(s): 02557061
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-03-25
Issued / Original Publication Date: 2025-07-08
Decision / Authorization Date: 2025-04-17
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/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/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