Review decisions

Showing 10 results of 254 total
Regulatory Decision Summary for Tyenne
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
Regulatory Decision Summary for Wainua
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1730840018921
Product Type: Drug
Control Number: 274598
DIN(s): 02548909
Manufacturer: AstraZeneca Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-04-21
Decision / Authorization Date: 2024-06-19
Regulatory Decision Summary for Zilbrysq
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
Regulatory Decision Summary for Cabtreo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1732553051076
Product Type: Drug
Control Number: 271199
DIN(s): 02550423
Manufacturer: Bausch Heath Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-06
Decision / Authorization Date: 2024-08-14
Regulatory Decision Summary for Plenvu
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
Regulatory Decision Summary for Miebo
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
Regulatory Decision Summary for Imfinzi
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
Regulatory Decision Summary for Rybelsus
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
Regulatory Decision Summary for Apretude
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
Regulatory Decision Summary for Breyanzi
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

Displaying 1 - 10 of 254 | Page 1 of 26
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