Basic Information
R06AX27
desloratadine
Antihistamines for systemic use
Therapeutic indication
Desloratadine Teva is indicated for the relief of symptoms associated with:
- allergic rhinitis;
- urticaria.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Desloratadine Teva. 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 Teva.
Active Substances (1)
desloratadine
Documents (10)
Desloratadine Teva : EPAR - Procedural steps taken and scientific information after authorisation
July 10, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine Teva : EPAR - All Authorised presentations
December 7, 2011
AUTHORISED_PRESENTATIONS
Desloratadine Teva : EPAR - Public assessment report
December 7, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Desloratadine Teva : EPAR - Product information
December 7, 2011
DRUG_PRODUCT_INFORMATION
Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
June 6, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine Teva : EPAR - Summary for the public
December 7, 2011
OVERVIEW_DOCUMENT
Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
June 9, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine Teva : EPAR - Public assessment report
December 7, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Desloratadine Teva
September 22, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Desloratadine Teva
September 22, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Overview Q&A (8)
Question
How does Desloratadine Teva work?
Answer
The active substance in Desloratadine Teva, desloratadine, is an antihistamine. It works by blocking the receptors on which histamine, a substance in the body that causes allergic symptoms, normally fixes itself. When the receptors are blocked, histamine cannot have its effect, and this leads to a decrease in the symptoms of allergy.
Question
What is Desloratadine Teva used for?
Answer
Desloratadine Teva 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.
Question
How is Desloratadine Teva used?
Answer
The recommended dose for adults and adolescents (12 years of age and over) is one tablet once a day.
Question
Other information about Desloratadine Teva
Answer
The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Teva on 24 November 2011.
For more information about treatment with Desloratadine Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Question
Why has Desloratadine Teva been approved?
Answer
The CHMP concluded that, in accordance with EU requirements, Desloratadine Teva 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 Teva be given marketing authorisation.
Question
What are the benefits and risks of Desloratadine Teva?
Answer
Because Desloratadine Teva 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.
Question
What is Desloratadine Teva?
Answer
Desloratadine Teva is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine Teva is a ‘generic medicine’. This means that Desloratadine Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius.
Question
How has Desloratadine Teva been studied?
Answer
Because Desloratadine Teva 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.