Basic Information
Xeplion
Regulatory Information
EMEA/H/C/002105
March 4, 2011
17
July 22, 2024
Company Information
Belgium
Turnhoutseweg 30 BE-2340 Beerse
Janssen-Cilag International NV
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Xeplion. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeplion.