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.
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.
Therapeutic Area (MeSH)
ATC Code
N05AX13
ATC Item
paliperidone
Pharmacotherapeutic Group
Psycholeptics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| paliperidone palmitate | N/A | 帕利哌酮 |
EMA Name
Xeplion
Medicine Name
Xeplion
Aliases
N/A
