What is Desloratadine Teva?
Desloratadine Teva is a medicine that contains the active substance desloratadine. The medicine is available in the form of tablets (5 mg).
Desloratadine Teva is a 'generic medicine'. This means that Desloratadine Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Aerius. For more information on generic medicines, see the questions and answers here.
What is Desloratadine Teva used for?
Desloratadine Teva is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an "allergy, such as hay fever or" dust mite allergy) or "hives (a skin condition caused by a" allergy, symptoms of which include itching and rash).
The medicine can only be obtained with a prescription.
How is Desloratadine Teva used?
The recommended dose for adults and adolescents (12 years and older) is one tablet once a day.
How does Desloratadine Teva work?
The active substance in Desloratadine Teva, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance present in the body that causes allergic symptoms, is normally fixed. Once the receptors are blocked, histamine fails to produce its effect and therefore a decrease in allergy symptoms is observed.
How has Desloratadine Teva been studied?
Because Desloratadine Teva is a generic medicine, the patient studies have been limited to establishing tests to determine that the medicine is bioequivalent to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Desloratadine Teva?
Because Desloratadine Teva 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.
Why has Desloratadine Teva been approved?
The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the CHMP considered that, as in the case of Aerius, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Desloratadine Teva.
More information about Desloratadine Teva
On 24 November 2011, the European Commission issued a "Marketing Authorization" for Desloratadine Teva, valid throughout the European Union.
For more information about Desloratadine Teva therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
The information on Desloratadine Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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