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ISTURISA osilodrostat (as phosphate) 5 mg film-coated tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
ISTURISA osilodrostat (as phosphate) 5 mg film-coated tablet blister pack
Approved
STANDARD
ISTURISA osilodrostat (as phosphate) 5 mg film-coated tablet blister pack
Recordati Rare Diseases Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
7c9ee99e66309aef
Company
Recordati Rare Diseases Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
7c9ee99e66309aef
Product Name
ISTURISA osilodrostat (as phosphate) 5 mg film-coated tablet blister pack
Artg Id
369218
Artg Name
ISTURISA osilodrostat (as phosphate) 5 mg film-coated tablet blister pack
Sponsor
Recordati Rare Diseases Australia Pty Ltd
Company Detail Path
/organization/recordati-rare-diseases-australia-pty-ltd
Artg Date
2022-05-12
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-01800-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-01430-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
7c9ee99e66309aef
Type
Standard
Back to TGA Approvals