Review decisions

Showing 160 results of 359 total
Summary Basis of Decision for Stoboclo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763476617645
Product Type: Drug
Control Number: 282455
DIN(s): 02560917
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
Summary Basis of Decision for Osenvelt
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1763475745099
Product Type: Drug
Control Number: 278930
DIN(s): 02560895
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-29
Issued / Original Publication Date: 2025-11-16
Decision / Authorization Date: 2025-09-17
Summary of Cancellation for Terbylac
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1747922265616
Product Type: Drug
Control Number: 281005
Manufacturer: Medexus Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Summary Basis of Decision for Omlyclo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740062351552
Product Type: Drug
Control Number: 279053
DIN(s): 02553805, 02553813
Manufacturer: Celltrion, Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-22
Issued / Original Publication Date: 2025-02-19
Decision / Authorization Date: 2024-12-06
Regulatory Decision Summary for Dupixent
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
Regulatory Decision Summary for Livmarli
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
Regulatory Decision Summary for Erleada
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
Regulatory Decision Summary for Mekinist
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
Summary Basis of Decision for Aflivu
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1754919110925
Product Type: Drug
Control Number: 282152
DIN(s): 02554178, 02554194
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-18
Issued / Original Publication Date: 2025-08-11
Decision / Authorization Date: 2025-06-26
Summary Basis of Decision for Vyloy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1740407272003
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada, Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2024-02-19
Decision / Authorization Date: 2024-12-13
Updated Date: 2025-08-18

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