What is Desloratadine ratiopharm?
Desloratadine ratiopharm is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine ratiopharm is a "generic medicine". This means that Desloratadine ratiopharm 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 by clicking here.
What is Desloratadine ratiopharm used for?
Desloratadine ratiopharm is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) or urticaria (skin disease caused by an allergy, whose symptoms include itching and rash).
The medicine can only be obtained with a prescription.
How is Desloratadine ratiopharm used?
The recommended dose for adults and adolescents (12 years of age and older) is 5 mg once a day.
How does Desloratadine ratiopharm work?
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. Once the receptors are blocked, histamine fails to produce its effect and this leads to a decrease in allergy symptoms.
How has Desloratadine ratiopharm been studied?
Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Aerius. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Desloratadine ratiopharm?
Because Desloratadine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Desloratadine ratiopharm been approved?
The CHMP concluded that, in accordance with EU requirements, Desloratadine ratiopharm 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 ratiopharm.
Further information on Desloratadine ratiopharm
On 13 January 2012, the European Commission granted a marketing authorization valid throughout the European Union for Desloratadine ratiopharm.
For more information about treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2011.
