Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

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: Sunovion Pharmaceuticals Europe Ltd
First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom
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
Updated with Decision(2015)5147 of 17/07/2015
26/03/2015 Centralised - Variation EMEA/H/C/2713/II/3/G
Updated with Decision(2015)5147 of 17/07/2015
21/07/2015 PSUSA - Modification EMEA/H/C/PSUSA/10114/201410 (2015)5147 of 17/07/2015
08/09/2015 Centralised - Variation EMEA/H/C/2713/IB/8
Updated with Decision(2016)143 of 11/01/2016
22/10/2015 Centralised - Variation EMEA/H/C/2713/II/9
Updated with Decision(2016)143 of 11/01/2016
13/01/2016 PSUSA - Modification EMEA/H/C/2713/PSUSA/10114 (2016)143 of 11/01/2016
22/01/2016 Corrigendum EMEA/H/C/2713/PSUSA/10114 (2016)143 of 11/01/2016
17/02/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2713/T/13 (2016)1052 of 15/02/2016
10/03/2016 Centralised - Variation EMEA/H/C/2713/IA/14/G