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The marketing authorisation for Allex has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 31/12/2009 .

Authorisation details

Product details

Product details for Allex
Agency product numberEMEA/H/C/000312
Active substance


International non-proprietary name (INN) or common name


Therapeutic area UrticariaRhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial
Anatomical therapeutic chemical (ATC) code R06AX27

Publication details

Publication details for Allex
Marketing-authorisation holder

Schering-Plough Europe

Date of issue of marketing authorisation valid throughout the European Union15/01/2001

Contact address:

SP Europe
Rue de Stalle, 73
B-1180 Bruxelles

Product information

Product information

31/12/2009  Allex -EMEA/H/C/000312


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Aerius is indicated for the relief of symptoms associated with:
- allergic rhinitis (see section 5.1)
- urticaria (see section 5.1)

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated


This medicine is now withdrawn from use in the European Union

More information on Allex