Review decisions

Showing 50 results of 2408 total
Regulatory Decision Summary for mResvia
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1736952828062
Product Type: Drug
Control Number: 279310
DIN(s): 02552914
Manufacturer: Moderna Biopharma Canada Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-21
Decision / Authorization Date: 2024-11-06
Regulatory Decision Summary for Veozah
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742493092656
Product Type: Drug
Control Number: 280470
DIN(s): 02553600
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-11-01
Decision / Authorization Date: 2024-12-02
Regulatory Decision Summary for Voranigo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1745430108554
Product Type: Drug
Control Number: 282910
DIN(s): 02551225, 02551233
Manufacturer: Servier Canada Inc.
Submission Type: New Drug Submission (New Active Substance) - Priority Review
Date Filed / Submission Date: 2024-01-17
Decision / Authorization Date: 2024-08-27
Regulatory Decision Summary for Vyloy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738680530505
Product Type: Drug
Control Number: 282144
DIN(s): 02553996
Manufacturer: Astellas Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2024-12-15
Decision / Authorization Date: 2024-12-13
Regulatory Decision Summary for Varivax III
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1738683735494
Product Type: Drug
Control Number: 280531
DIN(s): 02246081
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-10-31
Decision / Authorization Date: 2024-10-11
Regulatory Decision Summary for Omlyclo
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
Regulatory Decision Summary for Flucelvax
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1734719825446
Product Type: Drug
Control Number: 289304
DIN(s): 02553708, 02553716
Manufacturer: Seqirus UK Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2024-08-02
Decision / Authorization Date: 2024-12-03
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
Summary Safety Review - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel) - Chimeric Antigen Receptor T-cell (CAR-T) Therapies - Assessing the Potential Risk of Secondary T-cell Malignancy
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1733492722458
DIN(s): 02480514, 02485648, 02516667, 02527138, 02532719, 02535270
Issued / Original Publication Date: 2024-12-11
Updated Date: 2024-12-11

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