OPSUMIT macitentan 10 mg film coated tablet blister pack

Janssen-Cilag Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 307da75a89bc2739
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

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

307da75a89bc2739

Type

Standard