Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Latuda   
Auth. number : EU/1/14/913
Active substance : lurasidone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AE - Indole derivatives
Chemical substance: N05AE05 - Lurasidone
(See WHO ATC Index)
Indication: Latuda is indicated for the treatment of schizophrenia in adults aged 18 years and over
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
27/03/2014 Centralised - Authorisation EMEA/H/C/2713 (2014)2046 of 21/03/2014
04/07/2014 Centralised - Variation EMEA/H/C/2713/IB/1
Updated with Decision(2015)227 of 15/01/2015
19/01/2015 PSUSA - Modification EMEA/H/C/2713/PSUV/2 (2015)227 of 15/01/2015
18/02/2015 Centralised - Variation EMEA/H/C/2713/IB/5
26/03/2015 Centralised - Variation EMEA/H/C/2713/II/3/G