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HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial - TGA Drug Approval Details
Approvals
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TGA
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HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial
Approved
STANDARD
HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial
Endotherapeutics Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
a0b879d5dc384eb0
Company
Endotherapeutics Pty Ltd
Type
Standard
Approval Details
Approval Id
a0b879d5dc384eb0
Product Name
HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution vial plus diluent vial
Artg Id
318359
Artg Name
HEXVIX hexaminolevulinate (as hydrochloride) 85 mg powder for intravesical solution plus diluent
Sponsor
Endotherapeutics Pty Ltd
Company Detail Path
/organization/gmp-endotherapeutics-inc
Artg Date
2020-04-07
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Product Information
https://medical-cdn.nocode.com/drug_tga/941b36fe3b448dd2b1bf7bce38e6e5ee.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
a0b879d5dc384eb0
Type
Standard
Back to TGA Approvals