Desloratadine ratiopharm

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desloratadine

Authorised
This medicine is authorised for use in the European Union.

Overview

Desloratadine ratiopharm is a medicine used in adults to relieve the symptoms of the following conditions:

  • allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites).
  • chronic idiopathic urticaria (a recurrent skin condition with symptoms including itching and hives) as diagnosed by a doctor. ‘Idiopathic’ means that the cause of the disease is unknown.

Desloratadine ratiopharm contains the active substance desloratadine and is a ‘generic medicine’. This means that Desloratadine ratiopharm contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Aerius. For more information on generic medicines, see the question-and-answer document below.

This EPAR was last updated on 03/02/2021

Authorisation details

Product details
Name
Desloratadine ratiopharm
Agency product number
EMEA/H/C/002404
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
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Ratiopharm GmbH
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
13/01/2012
Contact address
Graf-Arco-Str. 3
D-89079 Ulm
Germany

Product information

24/11/2020 Desloratadine ratiopharm - EMEA/H/C/002404 - II/0023/G

Contents

  • 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

Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:

  • allergic rhinitis
  • chronic idiopathic urticaria as initially diagnosed by a physician

Assessment history

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