Opsaren 10 mg Film-coated Tablets

Licence status
Authorised: 06/02/2026
Active substances
Macitentan
Dosage Form
Film-coated tablet
Licence number
PA22865/018/001
Licence holder
Renata Pharmaceuticals (Ireland) Limited

Product documents

Licence information

ATC code
C02KX04 macitentan
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Marketing availability
Not marketed
Advertising conditions
Advertising to healthcare professionals only
Licence issued
06/02/2026