Active Substance: desloratadine
Common Name: desloratadine
ATC Code: R06AX27
Marketing Authorisation Holder: ratiopharm GmbH
Active Substance: desloratadine
Authorisation Date: 2012-01-13
Therapeutic Area: Urticaria Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial
Pharmacotherapeutic Group: Antihistamines for systemic use
Relief of symptoms associated with:
- allergic rhinitis;
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 authorised in the European Union (EU) called Aerius.
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, 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.
For more information about treatment with Desloratadine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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