Review decisions
Showing 160 results of 1549 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1752861229146
Product Type: Drug
Control Number: 287772
DIN(s): 02557010
Manufacturer: Ipsen Pharmaceuticals Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-06-19
Decision / Authorization Date: 2025-04-23
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758566878414
Product Type: Drug
Control Number: 285745
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-08
Decision / Authorization Date: 2025-04-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1745507324202
Product Type: Drug
Control Number: 285834
DIN(s): 02514400
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-04-10
Decision / Authorization Date: 2025-01-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753286280828
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
Decision / Authorization Date: 2025-04-14
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1744299053792
Product Type: Drug
Control Number: 284436
Manufacturer: Swedish Orphan Biovitrum Ab (publ)
Submission Type: New Drug Submission (New Active Substance) - Notice of Compliance with Conditions
Date Filed / Submission Date: 2024-02-29
Decision / Authorization Date: 2025-03-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1744297903847
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
Decision / Authorization Date: 2024-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758806289537
Product Type: Drug
Control Number: 273611
DIN(s): 02550075
Manufacturer: Dr. Reddy’s Laboratories Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-04-03
Decision / Authorization Date: 2024-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1757361952411
Product Type: Drug
Control Number: 271972
DIN(s): 02556472
Manufacturer: Formative Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-31
Decision / Authorization Date: 2025-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759431850340
Product Type: Drug
Control Number: 284770
DIN(s): 02514931
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2024-03-08
Decision / Authorization Date: 2024-10-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759769349421
Product Type: Drug
Control Number: 278913
DIN(s): 02551764, 02551772, 02551780, 02551799
Manufacturer: Blueprint Medicines Corporation/Medison Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-07
Decision / Authorization Date: 2024-09-18