Desloratadine ratiopharm

desloratadine

Overview
Authorisation details
Product information
Assessment history

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.

: Desloratadine ratiopharm can be obtained without a prescription. The medicine is available as tablets.

The recommended dose is one tablet once a day. The duration of treatment depends on the condition being treated.
If symptoms persist for more than 7 days or worsen, patients should seek medical advice. For more information about using Desloratadine ratiopharm, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Desloratadine ratiopharm, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Aerius, and do not need to be repeated for Desloratadine ratiopharm.
As for every medicine, the company provided studies on the quality of Desloratadine ratiopharm.
The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

: Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

: The European Medicines Agency concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the Agency’s view was that, as for Aerius, the benefits of Desloratadine ratiopharm outweigh the identified risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Desloratadine ratiopharm have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Desloratadine ratiopharm are continuously monitored. Side effects reported with Desloratadine ratiopharm are carefully evaluated and any necessary action taken to protect patients.

: Desloratadine ratiopharm received a marketing authorisation valid throughout the EU on 13 January 2012.

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Desloratadine ratiopharm : EPAR - Medicine overview (PDF/105.35 KB)

First published: 07/02/2012
Last updated: 03/02/2021
EMA/11520/2021
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Desloratadine ratiopharm : EPAR - Risk-management-plan summary (PDF/31.63 KB)

First published: 03/12/2020

This EPAR was last updated on 24/06/2022

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
Generic	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	12
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

22/06/2022 Desloratadine ratiopharm - EMEA/H/C/002404 - N/0030

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Desloratadine ratiopharm : EPAR - Product Information (PDF/358.59 KB)

First published: 07/02/2012
Last updated: 24/06/2022
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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.

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Desloratadine ratiopharm : EPAR - All Authorised presentations (PDF/19.58 KB)

First published: 07/02/2012
Last updated: 03/12/2020
- Bulgarian
  (PDF/38.52 KB)
- Croatian
  (PDF/27.87 KB)
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- Slovak
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- Slovenian
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- Spanish
  (PDF/16.59 KB)
- Swedish
  (PDF/19.48 KB)

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020

16/10/2020

Desloratadine ratiopharm

Table of contents

Overview