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DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 400 microgram/4 mL concentrated injection vial - TGA Drug Approval Details
Approvals
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TGA
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DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 400 microgram/4 mL concentrated injection vial
Approved
STANDARD
DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 400 microgram/4 mL concentrated injection vial
Medsurge Pharma Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
1936540bed1ae47c
Company
Medsurge Pharma Pty Ltd
Type
Standard
Approval Details
Approval Id
1936540bed1ae47c
Product Name
DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 400 microgram/4 mL concentrated injection vial
Artg Id
352310
Artg Name
DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 400 microgram/4 mL concentrated injection vial
Sponsor
Medsurge Pharma Pty Ltd
Company Detail Path
/organization/medsurge-pharma-pty-ltd
Artg Date
2021-11-11
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-CMI-01591-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
1936540bed1ae47c
Type
Standard
Back to TGA Approvals