Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xeplion   
Auth. number : EU/1/11/672
Active substance : paliperidone
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AX - Other antipsychotics
Chemical substance: N05AX13 - Paliperidone
(See WHO ATC Index)
Indication: XEPLION is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België
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
08/03/2011 Centralised - Authorisation EMEA/H/C/2105 (2011)1604 of 04/03/2011
14/10/2011 Centralised - Variation EMEA/H/C/2105/II/1 (2011)7393 of 12/10/2011
02/07/2012 Centralised - Variation EMEA/H/C/2105/II/3 (2012)4511 of 27/06/2012
25/07/2013 Centralised - Variation EMEA/H/C/2105/II/8
Updated with Decision(2013)5755 of 03/09/2013
05/09/2013 Centralised - Variation EMEA/H/C/2105/WS/403 (2013)5755 of 03/09/2013
06/12/2013 Centralised - 2-Monthly update EMEA/H/C/2105/II/9 (2013)8828 of 03/12/2013
21/10/2014 Centralised - Variation EMEA/H/C/2105/IAIN/18
Updated with Decision(2015)2121 of 23/03/2015
25/03/2015 PSUSA - Modification EMEA/H/C/2105/PSUV/16 (2015)2121 of 23/03/2015
25/06/2015 Centralised - Variation EMEA/H/C/2105/WS/700