Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nuedexta   
Auth. number : EU/1/13/833
INN : Dextromethorphan / quinidine
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N07 - Other nervous system drugs
Pharmacological subgroup: N07X - Other nervous system drugs
Chemical subgroup: N07XX - Other nervous system drugs
Chemical substance: N07XX - Other nervous system drugs
(See WHO ATC Index)
Indication: NUEDEXTA is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4). Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis
Marketing Authorisation Holder: Jenson Pharmaceutical Services Ltd
Carradine House 237 Regents Park Road, London N3 3LF, 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
26/06/2013 Centralised - Authorisation EMEA/H/C/833 (2013)4096 of 24/06/2013
03/04/2014 Centralised - Variation EMEA/H/C/833/IAin/2