Opulis

RSS

desloratadine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Opulis has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 19/05/2004

Authorisation details

Product details
Name
Opulis
Agency product number
EMEA/H/C/000311
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
Publication details
Marketing-authorisation holder
Schering-Plough Europe
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
15/01/2001
Contact address
SP Europe
Rue de Stalle, 73
B-1180 Bruxelles
Belgium

Product information

10/03/2004 Opulis - EMEA/H/C/000311 -

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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)

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