What is Dasselta - Desloratadine?
Dasselta is a drug containing the active ingredient desloratadine. The medicine is available as tablets (5 mg).
Dasselta is a "generic medicine". This means that Dasselta is similar to a "reference medicine" already authorized in the European Union (EU) called Aerius.
What is Dasselta - Desloratadine used for?
Dasselta 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 (a skin condition caused by an allergy). allergy, whose symptoms include itching and rash).
The medicine can only be obtained with a prescription.
How is Dasselta - Desloratadine used?
The recommended dose for adults and adolescents (ages 12 and up) is one tablet once a day.
How does Dasselta - Desloratadine work?
Desloratadine, the active ingredient in Dasselta, is an antihistamine. It works by blocking the receptors on which histamine, a substance present in the body that causes allergic symptoms, is usually fixed. Once the receptors are blocked, histamine fails to produce its effect and a decrease in allergy symptoms is observed.
What studies have been carried out on Dasselta - Desloratadine?
Because Dasselta is a generic medicine, studies in patients have been limited to tests to determine that the medicine is bioequivalent 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 Dasselta - Desloratadine?
Because Dasselta is a generic medicine and is bioequivalent to the reference medicine, its benefits are considered to be the same as the reference medicine's.
Why has Dasselta - Desloratadine been approved?
The CHMP concluded that, in accordance with EU requirements, Dasselta 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 that Dasselta be given marketing authorization.
More information on Dasselta - Desloratadine
On 28 November 2011, the European Commission issued a marketing authorization for Dasselta, valid throughout the European Union.
For more information on Dasselta therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
