Opsumit 2.5 mg film-coated tablets
- Licence status
- Active substances
- Macitentan
- Dosage Form
- Dispersible tablet
- Licence number
- EU/1/13/893/004
- Licence holder
- Janssen Pharmaceutica NV
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
- Conditions of Licence
- Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 19/09/2024