Overview

The marketing authorisation for Opulis has been withdrawn at the request of the marketing authorisation holder.

Product information

10/03/2004

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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
Opulis
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

Opulis 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/000311
Marketing authorisation holder
Schering-Plough Europe

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

Marketing authorisation issued
15/01/2001
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