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DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 400 micrograms/4 mL concentrated injection vial - TGA Drug Approval Details
Approvals
/
TGA
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DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 400 micrograms/4 mL concentrated injection vial
Approved
STANDARD
DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 400 micrograms/4 mL concentrated injection vial
Fresenius Kabi Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
79597067a3fa045a
Company
Fresenius Kabi Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
79597067a3fa045a
Product Name
DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 400 micrograms/4 mL concentrated injection vial
Artg Id
379590
Artg Name
DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 400 micrograms/4 mL concentrated injection vial
Sponsor
Fresenius Kabi Australia Pty Ltd
Company Detail Path
/organization/fresenius-kabi-australia-pty-ltd
Artg Date
2022-11-23
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
79597067a3fa045a
Type
Standard
Back to TGA Approvals