Tracleer 62.5 mg film-coated tablets
- Licence status
- Active substances
- Bosentan
- Dosage Form
- Film-coated tablet
- Licence number
- EU/1/02/220/001
- Licence holder
- Janssen-Cilag International NV
Product documents
Licence information
- ATC code
- C02KX Other antihypertensives, C02KX01 bosentan
- 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