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HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector - TGA Drug Approval Details
Approvals
/
TGA
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HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector
Approved
STANDARD
HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector
Samsung Bioepis AU Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
311545fa70076c77
Company
Samsung Bioepis AU Pty Ltd
Type
Standard
Approval Details
Approval Id
311545fa70076c77
Product Name
HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector
Artg Id
384975
Artg Name
HADLIMA adalimumab 40 mg/0.4 mL solution for injection in PushTouch auto-injector
Sponsor
Samsung Bioepis AU Pty Ltd
Company Detail Path
/organization/samsung-bioepis-au-pty-ltd
Artg Date
2023-02-15
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-2021-CMI-01179-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-01180-1
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
311545fa70076c77
Type
Standard
Back to TGA Approvals