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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/950479/2011

EMEA/H/C/002404

EPAR summary for the public

Desloratadine ratiopharm

desloratadine

This is a summary of the European public assessment report (EPAR) for Desloratadine ratiopharm. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Desloratadine ratiopharm.

What is Desloratadine ratiopharm?

Desloratadine ratiopharm is a medicine containing the active substance desloratadine. It is available as tablets (5mg).

Desloratadine ratiopharm is a 'generic medicine'. This means that Desloratadine ratiopharm is similar to a 'reference medicine' already authorised in the European Union (EU) called Aerius. For more information on generic medicines, see the question-and-answer document 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, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).

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 over) 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,

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normally attaches itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.

How has Desloratadine ratiopharm been studied?

Because Desloratadine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it 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 ratiopharm?

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.

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's view was that, as for Aerius, the benefit outweighs the identified risk. The Committee recommended that Desloratadine ratiopharm be given marketing authorisation.

Other information about Desloratadine ratiopharm

The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine ratiopharm on 13 January 2012.

The full EPAR for Desloratadine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 12-2011.

Desloratadine ratiopharm

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