Johnson & Johnson — Trevicta (previously Paliperidone Janssen) EMA EPAR public assessment report (EMEA/H/C/004066, 2014)
Johnson & Johnson · 2014 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the marketing authorization application for Trevicta (previously Paliperidone Janssen), an informed consent application referencing the approved Xeplion. Submitted by Janssen-Cilag International N.V. in August 2014, the application sought approval for the maintenance treatment of schizophrenia in adults. The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Marketing Authorisation on October 23, 2014, based on Trevicta's identical quality, safety, and efficacy profile to Xeplion.
Key findings — cited to the page
| Potential risk | Gastrointestinal obstruction (INVEGA only) | INVEGA · p.8 |
| Potential risk | Decreased bone mineral density/Osteoporosis | · p.8 |
| Study type | randomised, double-blind, placebo-controlled, parallel-group study | R092670-SCA-3004 · p.8 |
| Study objective | evaluate the efficacy of XEPLION compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder | R092670-SCA-3004 · p.8 |
| Study objective | assess the safety and tolerability of XEPLION in subjects with schizoaffective disorder | R092670-SCA-3004 · p.8 |
| Final study report planned | July 2014 | R092670-SCA-3004 · p.8 |
| PASS of cardiovascular and cerebrovascular adverse events in elderly patients | End 2015 | · p.9 |
| Drug utilisation study submission date | August /September 2014 | · p.9 |
| Application submission date | 7 August 2014 | Paliperidone Janssen · p.4 |
| CHMP positive opinion date | 23 October 2014 | Paliperidone Janssen · p.5 |
| Marketing Authorisation for Xeplion | 4 March 2011 | Xeplion · Community · p.4 |
| Identified risk | Rhabdomyolysis | · p.7 |
Source: Johnson & Johnson ↗ · 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 →