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SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe - TGA Drug Approval Details
Approvals
/
TGA
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SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
Approved
STANDARD
SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
Janssen-Cilag Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
c0d33f36b6857fe5
Company
Janssen-Cilag Pty Ltd
Type
Standard
Approval Details
Approval Id
c0d33f36b6857fe5
Product Name
SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
Artg Id
208278
Artg Name
SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe
Sponsor
Janssen-Cilag Pty Ltd
Company Detail Path
/organization/janssen-cilag-pty-ltd
Artg Date
2014-04-02
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-2011-CMI-03026-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2011-PI-03025-3
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
c0d33f36b6857fe5
Type
Standard
Back to TGA Approvals