Review decisions

Showing 10 results of 820 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 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 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 Armlupeg
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724332454521
Product Type: Drug
Control Number: 262990
Manufacturer: Lupin Pharma Canada Limited
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-03-31
Decision / Authorization Date: 2024-08-16
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 Pyzchiva / Pyzchiva I.V. (ustekinumab)
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724778020977
Product Type: Drug
Control Number: 278712
DIN(s): 02550520, 02550539, 02550547
Manufacturer: Samsung Bioepis Co., Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-08-30
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 Okedi
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1722527517248
Product Type: Drug
Control Number: 264840
DIN(s): 02544601, 02544628
Manufacturer: Laboratorios Farmaceuticos Rovi, S.A.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2022-06-03
Decision / Authorization Date: 2024-03-21

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