Latuda

lurasidone

Table of contents

Opinion

On 23 July 2020, 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 Latuda. The marketing authorisation holder for this medicinal product is Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

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

Latuda is indicated for the treatment of schizophrenia in adults aged 18 years and adolescent aged 13 years and over.

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 will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold, removed text as strikethrough

Key facts

Name
Latuda
Agency product number
EMEA/H/C/002713
International non-proprietary name (INN) or common name
  • lurasidone
Active substance
  • lurasidone
Therapeutic area
Schizophrenia
Date opinion adopted
23/07/2020
Company name
Aziende Chimiche Riunite Angelini Francesco S.p.A.
Status
Positive
Application type
Post-authorisation

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