Allex

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Withdrawn

This medicine's authorisation has been withdrawn

desloratadine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 2 February 2004 the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Markething Authorisation for Allex for commercial reasons. On 10 March 2004 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product Allex.

Product information

31/12/2009
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This medicine’s product information is available in all official EU languages.
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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Product details

Name of medicine
Allex
Active substance
desloratadine
International non-proprietary name (INN) or common name
desloratadine
Therapeutic area (MeSH)
  • Rhinitis, Allergic, Perennial
  • Urticaria
  • Rhinitis, Allergic, Seasonal
Anatomical therapeutic chemical (ATC) code
R06AX27

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)

Authorisation details

EMA product number
EMEA/H/C/000312
Marketing authorisation holder
Schering-Plough Europe

SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium

Marketing authorisation issued
15/01/2001
Withdrawal of marketing authorisation
10/03/2004
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