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DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule - TGA Drug Approval Details
Approvals
/
TGA
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DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule
Approved
STANDARD
DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule
Orion Pharma (AUS) Pty Limited
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
f56cd1342757f7aa
Company
Orion Pharma (AUS) Pty Limited
Type
Standard
Approval Details
Approval Id
f56cd1342757f7aa
Product Name
DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule
Artg Id
379412
Artg Name
DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule
Sponsor
Orion Pharma (AUS) Pty Limited
Company Detail Path
/organization/orion-pharma-aus-pty-limited
Artg Date
2022-11-14
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/133c1ef12f0e87d88dafb4d1ed7ca547.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/394f18afc0fabd95a58aa6566c3d4ed2.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
f56cd1342757f7aa
Type
Standard
Back to TGA Approvals