Review decisions
Showing 10 results of 132 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1735063121561
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
Decision / Authorization Date: 2024-12-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734622818009
Product Type: Drug
Control Number: 279567
DIN(s): 02531836
Manufacturer: Telix Pharmaceuticals (US) Inc
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-06
Decision / Authorization Date: 2024-09-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1729607296633
Product Type: Drug
Control Number: 280011
DIN(s): 02552450, 02552469, 02552477, 02552485, 02552493
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-10-17
Decision / Authorization Date: 2024-10-11
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732026718824
Product Type: Drug
Control Number: 276757
DIN(s): 02549220, 02549239, 02549247
Manufacturer: UCB Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-11
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