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OPSUMIT (Janssen-Cilag Pty Ltd)
Product name
OPSUMIT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
210 (255 working days)
Active ingredients
macitentan
Registration type
EOI
Indication
Paediatric (2 years to less than 18 years of age)
OPSUMIT, as monotherapy or in combination, is indicated for the treatment of:
- idiopathic pulmonary arterial hypertension
- heritable pulmonary arterial hypertension
- pulmonary arterial hypertension associated with connective tissue disease
- pulmonary arterial hypertension associated with congenital heart disease with repaired shunts
- pulmonary arterial hypertension with co-incidental congenital heart disease in paediatric patients with WHO Functional class I, II, III or IV symptoms.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.