TGA Approval

OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack (420130)

ARTG ID

420130

ARTG Name

OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack

Sponsor

Janssen-Cilag Pty Ltd

ARTG Date

September 16, 2024

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

JANSSEN-CILAG PTY LTD

https://medical-cdn.nocode.com/drug_tga/e7117bb29a5ef9c6453f9c32c78f7dec.pdf

https://medical-cdn.nocode.com/drug_tga/95dc336ee1558182c4f1fe51a79f35b6.pdf

Ingredient Name

macitentan

Ingredient Name

tadalafil

Empowering clinical research with data-driven insights and AI-powered tools.

OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack (420130) - TGA 批准文号 | MedPath