Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Nexium Control   
Auth. number : EU/1/13/860
INN : esomeprazole
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A02 - Drugs for acid related disorders
Pharmacological subgroup: A02B - Drugs for treatment of peptic ulcer
Chemical subgroup: A02BC - Proton pump inhibitors
Chemical substance: A02BC05 - Esomeprazole
(See WHO ATC Index)
Indication: Nexium Control is indicated for the short term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults
Marketing Authorisation Holder: Pfizer Consumer Healthcare Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ, 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
29/08/2013 Centralised - Authorisation EMEA/H/C/2618 (2013)5615 of 26/08/2013
29/10/2013 Centralised - Variation EMEA/H/C/2618/IA/2/G
Updated with Decision(2014)2060 of 21/03/2014
23/01/2014 Centralised - Variation EMEA/H/C/2618/II/1
Updated with Decision(2014)2060 of 21/03/2014
25/03/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2618/T/4 (2014)2060 of 21/03/2014
24/06/2014 Centralised - Variation EMEA/H/C/2618/IB/5