Rxulti - opinion on variation to marketing authorisation

On 30 January 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Rxulti. The marketing authorisation holder for this medicinal product is Otsuka Pharmaceutical Netherlands B.V.

The CHMP adopted an extension to the existing indication as follows:¹

Rxulti is indicated for the treatment of schizophrenia in adults and adolescents aged 13 years and older.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and made available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

¹New text in bold