Balversa 3 mg Film-coated tablet

Licence status
Authorised: 22/08/2024
Active substances
Erdafitinib
Dosage Form
Film-coated tablet
Licence number
EU/1/24/1841/001-004
Licence holder
Janssen-Cilag International NV

Product documents

Licence information

ATC code
L01EN01 erdafitinib
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
22/08/2024