Review decisions

Showing 20 results of 2299 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732551487982
Product Type: Drug
Control Number: 273065
Manufacturer: Bausch Health Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-03-03
Decision / Authorization Date: 2024-08-16
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732548590090
Product Type: Drug
Control Number: 272066
DIN(s): 02551403
Manufacturer: Bausch & Lomb Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-23
Decision / Authorization Date: 2024-09-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729085441755
Product Type: Drug
Control Number: 281318
DIN(s): 02468816
Manufacturer: AstraZeneca Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-20
Decision / Authorization Date: 2024-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729098917291
Product Type: Drug
Control Number: 281745
DIN(s): 02551012, 02551020, 02551039
Manufacturer: Novo Nordisk Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-12-01
Decision / Authorization Date: 2024-10-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732302431707
Product Type: Drug
Control Number: 280033
Manufacturer: ViiV Healthcare ULC
Submission Type: NDS for Priority Review
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-05-10
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1728568404321
Product Type: Drug
Control Number: 279827
DIN(s): 02527138
Manufacturer: Bristol-Myers Squibb Canada
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-11
Decision / Authorization Date: 2024-09-25
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727378042656
Product Type: Drug
Control Number: 279552
DIN(s): 02505541, 02505568
Manufacturer: Celgene Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-09-29
Decision / Authorization Date: 2024-09-13
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1727284854344
Product Type: Drug
Control Number: 278399
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-21
Decision / Authorization Date: 2024-08-29
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1726763640809
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
Decision / Authorization Date: 2024-09-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730994785079
Product Type: Drug
Control Number: 273356
DIN(s): 02551810, 02551829, 02551837
Manufacturer: Apotex Inc.
Submission Type: Abbreviated New Drug Submission
Date Filed / Submission Date: 2023-05-10
Decision / Authorization Date: 2024-09-17