Review decisions

Showing 10 results of 139 total
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 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 Apo-Vilazodone
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
Regulatory Decision Summary for Adheroza
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1725633192834
Product Type: Drug
Control Number: 275910
DIN(s): 02550970, 02550989
Manufacturer: Accord Healthcare Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-01
Decision / Authorization Date: 2024-08-20
Regulatory Decision Summary for Pyzchiva / Pyzchiva I.V. (ustekinumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724776566772
Product Type: Drug
Control Number: 277532
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-07-26
Decision / Authorization Date: 2024-08-07
Regulatory Decision Summary for Steqeyma/Steqeyma IV
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722628438095
Product Type: Drug
Control Number: 274939
DIN(s): 02550245, 02550253, 02550261
Manufacturer: Celltrion Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-06-30
Decision / Authorization Date: 2024-07-30
Regulatory Decision Summary for Vabysmo
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722952436074
Product Type: Drug
Control Number: 278042
DIN(s): 02527618
Manufacturer: Hoffmann-La Roche Limited
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-08-08
Decision / Authorization Date: 2024-07-24
Regulatory Decision Summary for Xenpozyme
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1723644947965
Product Type: Drug
Control Number: 275236
DIN(s): 02545713, 02545721
Manufacturer: Sanofi-Aventis Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-05-12
Decision / Authorization Date: 2024-02-28

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