Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Adasuve   
Auth. number : EU/1/13/823
Active substance : loxapine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05A - Antipsychotics
Chemical subgroup: N05AH - Diazepines, oxazepines, thiazepines and oxepines
Chemical substance: N05AH01 - loxapine
(See WHO ATC Index)
Indication: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Marketing Authorisation Holder: Ferrer Internacional S.A.
Gran Via Carlos III, 94 08028 Barcelona , España
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
25/02/2013 Centralised - Authorisation EMEA/H/C/2400 (2013)1093 of 20/02/2013
11/04/2013 Corrigendum (2013)2106 of 09/04/2013
03/05/2013 Centralised - Variation EMEA/H/C/2400/IB/2/G
Updated with Decision(2014)3821 of 03/06/2014
26/06/2013 Corrigendum (2013)1093 of 20/02/2013
08/04/2014 Centralised - Variation EMEA/H/C/2400/IB/6
Updated with Decision(2014)3821 of 03/06/2014
05/06/2014 Centralised - Yearly update (2014)3821 of 03/06/2014
25/09/2014 Centralised - Variation EMEA/H/C/2400/II/9
Updated with Decision(2015)6047 of 25/08/2015
23/10/2014 Centralised - Variation EMEA/H/C/2400/II/10/G
Updated with Decision(2015)6047 of 25/08/2015
06/07/2015 Centralised - Variation EMEA/H/C/2400/IB/16/G
Updated with Decision(2015)6047 of 25/08/2015
27/08/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2400/T/17 (2015)6047 of 25/08/2015
28/10/2015 Centralised - Notification EMEA/H/C/2400/N/18
Updated with Decision(2018)251 of 15/01/2018
28/11/2016 Centralised - Notification EMEA/H/C/2400/N/21
Updated with Decision(2018)251 of 15/01/2018
17/01/2018 Centralised - Renewal EMEA/H/C/2400/R/24 (2018)251 of 15/01/2018