UCB SA — Lacosamide UCB EMA EPAR public assessment report (EMEA/H/C/005243, 2019)
UCB SA · 2019 · EMA EPAR public assessment report · company profile →
Report summary
The EMA Public Assessment Report for Lacosamide UCB details the regulatory approval of this antiepileptic drug. It is indicated for partial-onset seizures in adults, adolescents, and children aged 4 years and older. Lacosamide UCB was approved via an informed consent application, referencing the original product, Vimpat. The report also covers the established risk management plan and pharmacovigilance activities to ensure its safe use.
Key findings — cited to the page
| Vimpat monotherapy approval age | 16 years and older | Vimpat · p.8 |
| Original Vimpat marketing authorisation date | 29 August 2008 | Vimpat · EU · p.5 |
| Lacosamide UCB indication age range | 4 years of age | Lacosamide UCB · EU · p.2 |
| Lacosamide UCB indication age range | 4 years of age | Lacosamide UCB · EU · p.5 |
| Lacosamide UCB indication age range | 4 years of age | Lacosamide UCB · EU · p.8 |
| Lacosamide UCB indication age range | 4 years of age | Lacosamide UCB · EU · p.13 |
| Marketing Authorisation Application submission date | 2 April 2019 | Lacosamide UCB · EU · p.5 |
| CHMP positive opinion date | 27 June 2019 | Lacosamide UCB · EU · p.6 |
Source: UCB SA ↗ · 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 Neurology library →