Review decisions

Showing 10 results of 1327 total
Regulatory Decision Summary for Illuccix
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
Regulatory Decision Summary for Jamteki / Jamteki I.V.
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734360561368
Product Type: Drug
Control Number: 285419
DIN(s): 02543036, 02543044, 02553120
Manufacturer: JAMP Pharma Corporation
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2024-03-28
Decision / Authorization Date: 2024-11-13
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 Clorotekal
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1733408271619
Product Type: Drug
Control Number: 270862
DIN(s): 02551063
Manufacturer: B. Braun Melsungen AG
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-12-29
Decision / Authorization Date: 2024-08-22
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

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