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OPSYNVI (Janssen-Cilag Pty Ltd)
Product name
OPSYNVI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
macitentan, tadalafil
Registration type
New combination
Indication
OPSYNVI is indicated for the maintenance treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) in adult patients of WHO functional class (FC) II and III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease with repaired shunts.
OPSYNVI is intended as substitution treatment only for patients currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.