Macitentan Accord 10 mg film-coated tablets
- Licence status
- Active substances
- Macitentan
- Dosage Form
- Film-coated tablet
- Licence number
- EU/1/25/1970/001-008
- Licence holder
- Accord Healthcare S.L.U.
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
- 24/09/2025