What is Desloratadine Actavis?
Desloratadine Actavis is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine Actavis is a "generic medicine". This means that Desloratadine Actavis 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 Actavis used for?
Desloratadine Actavis is used to get relief from 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 Actavis used?
The recommended dose for adults and adolescents (12 years of age and older) is 5 mg once a day.
How does Desloratadine Actavis work?
The active substance in Desloratadine Actavis, 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 Actavis been studied?
Because Desloratadine Actavis 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 Actavis?
Because Desloratadine Actavis 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 Actavis been approved?
The CHMP concluded that, in accordance with EU requirements, Desloratadine Actavis 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 Actavis.
More information on Desloratadine Actavis
On 13 January 2012, the European Commission issued a marketing authorization for Desloratadine Actavis, valid throughout the European Union.
For more information on treatment with Desloratadine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 12-2011.
