Basic Information
R06AX27
desloratadine
Antihistamines for systemic use
Therapeutic indication
Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:
- allergic rhinitis
- chronic idiopathic urticaria as initially diagnosed by a physician
Overview Summary
Desloratadine ratiopharm is a medicine used in adults to relieve the symptoms of the following conditions:
- allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites).
- chronic idiopathic urticaria (a recurrent skin condition with symptoms including itching and hives) as diagnosed by a doctor. ‘Idiopathic’ means that the cause of the disease is unknown.
Desloratadine ratiopharm contains the active substance desloratadine and is a ‘generic medicine’. This means that Desloratadine ratiopharm contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Aerius. For more information on generic medicines, see the question-and-answer document below.
Active Substances (1)
desloratadine
Documents (13)
CHMP summary of positive opinion for Desloratadine ratiopharm
November 17, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Desloratadine ratiopharm : EPAR - Public assessment report
February 6, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Desloratadine ratiopharm-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 ratiopharm : EPAR - Risk-management-plan summary
December 3, 2020
RISK_MANAGEMENT_PLAN_SUMMARY
Desloratadine ratiopharm : EPAR - Medicine overview
February 6, 2012
OVERVIEW_DOCUMENT
CHMP post-authorisation summary of positive opinion for Desloratadine ratiopharm (II-23-G)
October 16, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine ratiopharm : EPAR - All Authorised presentations
February 6, 2012
AUTHORISED_PRESENTATIONS
Desloratadine ratiopharm : EPAR - Public assessment report
February 6, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Desloratadine ratiopharm
November 17, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine ratiopharm : EPAR - Procedural steps taken and scientific information after authorisation
October 8, 2013
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine ratiopharm-H-C-2404-II-0023-G : EPAR - Assessment report - Variation
December 3, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine ratiopharm-H-C-PSUSA-962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
May 29, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine ratiopharm : EPAR - Product Information
February 6, 2012
DRUG_PRODUCT_INFORMATION
Overview Q&A (7)
Question
How is Desloratadine ratiopharm used?
Answer
Desloratadine ratiopharm can be obtained without a prescription. The medicine is available as tablets.
The recommended dose is one tablet once a day. The duration of treatment depends on the condition being treated.
If symptoms persist for more than 7 days or worsen, patients should seek medical advice. For more information about using Desloratadine ratiopharm, see the package leaflet or contact your doctor or pharmacist.
Question
How does Desloratadine ratiopharm work?
Answer
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.
Question
Why is Desloratadine ratiopharm authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Desloratadine ratiopharm has been shown to have comparable quality and to be bioequivalent to Aerius. Therefore, the Agency’s view was that, as for Aerius, the benefits of Desloratadine ratiopharm outweigh the identified risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Desloratadine ratiopharm?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Desloratadine ratiopharm have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Desloratadine ratiopharm are continuously monitored. Side effects reported with Desloratadine ratiopharm are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Desloratadine ratiopharm
Answer
Desloratadine ratiopharm received a marketing authorisation valid throughout the EU on 13 January 2012.
Question
How has Desloratadine ratiopharm been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Aerius, and do not need to be repeated for Desloratadine ratiopharm.
As for every medicine, the company provided studies on the quality of Desloratadine ratiopharm.
The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Question
What are the benefits and risks of Desloratadine ratiopharm?
Answer
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.