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

Approved

STANDARD

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

Janssen-Cilag Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: fef3724ad32a15f0
Product Name: OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack
Artg Id: 420130
Artg Name: OPSYNVI 10/40 macitentan 10 mg / tadalafil 40 mg film-coated tablet blister pack
Sponsor: Janssen-Cilag Pty Ltd
Company Detail Path: /organization/janssen-cilag-pty-ltd
Artg Date: 2024-09-16
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/e7117bb29a5ef9c6453f9c32c78f7dec.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/95dc336ee1558182c4f1fe51a79f35b6.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

fef3724ad32a15f0

Type

Standard