Opulis

Withdrawn

This medicine's authorisation has been withdrawn

desloratadine

Overview

On 15 January 2001 the European Commission granted a marketing authorisation for the whole European Union to SP Europe, for Opulis (desloratadine), indicated for the relief of symptoms associated with allergic rhinitis (AR) and with chronic idiopathic urticaria (CIU).

Opulis was not marketed anywhere in the European Union. On 2 February 2004 the Marketing Authorisation Holder notified the European Commission of its decision to volunatarily withdraw the Marketing Authorisation for Opulis for commercial reasons. There are still three Community Marketing Authorisations valid throughout the European Union for medicinal products containing desloratadine i.e. Aerius, Azomyr and Neoclarityn.

On 10 March 2004 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use "Opulis". Pursuant to this decision the European Public Assessment Report for Opulis has been removed from this website.

Product information

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
• Withdrawal of marketing authorisation:
  10/03/2004