Unknown MAH — Byannli (previously Paliperidone Janssen-Cilag International) EMA EPAR public assessment report (EMEA/H/C/005486, 2020)
Unknown MAH · 2020 · EMA EPAR public assessment report
Report summary
The EMA's CHMP assessed Paliperidone Janssen-Cilag International, a duplicate of Xeplion, under an informed consent procedure. The application, sharing identical quality, non-clinical, and clinical data with Xeplion, received a positive CHMP opinion for marketing authorization. This approval is for the maintenance treatment of schizophrenia in adult patients.
Key findings — cited to the page
| Marketing authorization opinion date | 30 April 2020 | Paliperidone Janssen-Cilag International · European Union · p.4 |
| Indication | maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone | Paliperidone Janssen-Cilag International · European Union · p.3 |
| Indication | In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Paliperidone Janssen-Cilag International may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. | Paliperidone Janssen-Cilag International · European Union · p.3 |
| Legal basis for application | Article 10(c) of Directive 2001/83/EC | Paliperidone Janssen-Cilag International · European Union · p.3 |
| Active substance status | known active substance | paliperidone · p.3 |
| Pharmacovigilance system summary | fulfils the requirements of Article 8(3) of Directive 2001/83/EC | · p.8 |
Source: Unknown MAH ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →