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OPSUMIT macitentan 10 mg film coated tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
/
OPSUMIT macitentan 10 mg film coated tablet blister pack
Approved
STANDARD
OPSUMIT macitentan 10 mg film coated tablet blister pack
Janssen-Cilag Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
05953de9b830a84b
Company
Janssen-Cilag Pty Ltd
Type
Standard
Approval Details
Approval Id
05953de9b830a84b
Product Name
OPSUMIT macitentan 10 mg film coated tablet blister pack
Artg Id
205624
Artg Name
OPSUMIT macitentan 10 mg film coated tablet blister pack
Sponsor
Janssen-Cilag Pty Ltd
Company Detail Path
/organization/janssen-cilag-pty-ltd
Artg Date
2014-02-05
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/6ba383224505b234b9c6f8cb3cfe871d.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/f7fe287f918277d36d25b3ecb23a2b59.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
05953de9b830a84b
Type
Standard
Back to TGA Approvals