Review decisions
Showing 140 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1755022842278
Product Type: Drug
Control Number: 284185
DIN(s): 02473232, 02496135
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-02-22
Decision / Authorization Date: 2025-07-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1756129266390
Product Type: Drug
Control Number: 288497
DIN(s): 02322285
Manufacturer: Alexion Pharma GmbH
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-07-11
Decision / Authorization Date: 2025-08-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1755092657469
Product Type: Drug
Control Number: 291743
DIN(s): 02541769
Manufacturer: Ultragenyx Pharmaceutical Inc
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-11-04
Decision / Authorization Date: 2025-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763649652922
Product Type: Drug
Control Number: 276831
DIN(s): 02557037
Manufacturer: Hikma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2025-04-24
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759938964937
Product Type: Drug
Control Number: 264421
DIN(s): 02510219, 02510227, 02558947, 02558955
Manufacturer: KYE Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2022-05-19
Decision / Authorization Date: 2025-06-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1763043055034
Product Type: Drug
Control Number: 271063
DIN(s): 02557592
Manufacturer: Chiesi Farmaceutici S.p.a.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-30
Decision / Authorization Date: 2025-05-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753456518317
Product Type: Drug
Control Number: 280633
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-11-06
Decision / Authorization Date: 2025-07-15
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753987106919
Product Type: Drug
Control Number: 285622
Manufacturer: Amivas Ireland Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-04-03
Decision / Authorization Date: 2025-07-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752862833837
Product Type: Drug
Control Number: 274979
DIN(s): 02556081
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-10-06
Decision / Authorization Date: 2025-03-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752764358755
Product Type: Drug
Control Number: 282152
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-18
Decision / Authorization Date: 2025-06-26