Review decisions

Showing 10 results of 2322 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776957390008
Product Type: Drug
Control Number: 294382
DIN(s): 02567393, 02567407, 02567415, 02567423
Manufacturer: JAMP Pharma Corporation
Submission Type: New Drug Submission
Date Filed / Submission Date: 2025-04-25
Decision / Authorization Date: 2026-04-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776954365092
Product Type: Drug
Control Number: 279513
Manufacturer: Dr Reddys Laboratories Ltd
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2024-01-05
Decision / Authorization Date: 2026-04-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776867861872
Product Type: Drug
Control Number: 293948
DIN(s): 02567121
Manufacturer: ALK-Abello A/S
Submission Type: New Drug Submission
Date Filed / Submission Date: 2025-01-06
Decision / Authorization Date: 2026-04-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776880513456
Product Type: Drug
Control Number: 298071
DIN(s): 02566125
Manufacturer: Mint Pharmaceuticals Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2025-07-09
Decision / Authorization Date: 2026-02-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1776440503744
Product Type: Drug
Control Number: 292796
DIN(s): 02565234, 02565242, 02565250, 02565269, 02565277
Manufacturer: Mirum Pharmaceuticals Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-11-28
Decision / Authorization Date: 2026-01-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1777039862924
Product Type: Drug
Control Number: 293084
DIN(s): 02566648
Manufacturer: Apotex Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2025-01-10
Decision / Authorization Date: 2026-03-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774272110553
Product Type: Drug
Control Number: 295688
DIN(s): 02566680
Manufacturer: Ferring Inc
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-03-04
Decision / Authorization Date: 2026-03-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774886128760
Product Type: Drug
Control Number: 298254
DIN(s): 02467550, 02522470
Manufacturer: AbbVie corp.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2025-05-22
Decision / Authorization Date: 2025-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1774891408116
Product Type: Drug
Control Number: 296713
DIN(s): 02565323
Manufacturer: Merck Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2025-04-01
Decision / Authorization Date: 2026-01-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1772568306882
Product Type: Drug
Control Number: 280385
Manufacturer: Dr. Reddy's Laboratories SA
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-27
Decision / Authorization Date: 2026-02-13