Review decisions

Showing 60 results of 768 total
Summary Basis of Decision for Kavigale
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1749130248379
Product Type: Drug
Control Number: 283047
DIN(s): 02556332
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance) (COVID-19)
Date Filed / Submission Date: 2024-01-23
Issued / Original Publication Date: 2025-06-05
Decision / Authorization Date: 2025-03-21
Summary Basis of Decision for Voranigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1733494552846
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Issued / Original Publication Date: 2024-12-05
Decision / Authorization Date: 2024-08-27
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 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
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
Summary Basis of Decision for Otulfi and Otulfi I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1750276558621
Product Type: Drug
Control Number: 279373
DIN(s): 02554283, 02554291, 02554305
Manufacturer: Fresenius Kabi Canada Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-15
Issued / Original Publication Date: 2025-06-18
Decision / Authorization Date: 2024-12-30
Summary Basis of Decision for Anzupgo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1766090045444
Product Type: Drug
Control Number: 282015
DIN(s): 02560704
Manufacturer: Leo Pharma Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-12-13
Issued / Original Publication Date: 2025-12-19
Decision / Authorization Date: 2025-12-23
Summary Basis of Decision for Imdelltra
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1739374529873
Product Type: Drug
Control Number: 281963
DIN(s): 02551551, 02551578
Manufacturer: Amgen Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2023-12-11
Issued / Original Publication Date: 2025-02-11
Decision / Authorization Date: 2024-09-11
Updated Date: 2026-02-02

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