Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
This is a summary of the European public assessment report (EPAR) for Desloratadine Actavis. 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 Actavis.
Active Substances (1)
desloratadine
Documents (10)
Desloratadine Actavis : EPAR - Public assessment report
January 24, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Desloratadine Actavis : EPAR - Product Information
January 24, 2012
DRUG_PRODUCT_INFORMATION
Desloratadine Actavis : EPAR - All Authorised presentations
January 24, 2012
AUTHORISED_PRESENTATIONS
Desloratadine Actavis : EPAR - Summary for the public
January 24, 2012
OVERVIEW_DOCUMENT
Desloratadine Actavis : EPAR - Procedural steps taken and scientific information after authorisation
March 18, 2014
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine Actavis : EPAR - Public assessment report
January 24, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Desloratadine Actavis
November 17, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Desloratadine Actavis-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 Actavis-H-C-PSUSA-962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
May 30, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Desloratadine Actavis
November 17, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Overview Q&A (8)
Question
What are the benefits and risks of Desloratadine Actavis?
Answer
Because Desloratadine Actavis 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
How is Desloratadine Actavis used?
Answer
The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.
Question
How does Desloratadine Actavis work?
Answer
The active substance in Desloratadine Actavis, 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
Other information about Desloratadine Actavis
Answer
The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Actavis on 13 January 2012.
For more information about treatment with Desloratadine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Question
How has Desloratadine Actavis been studied?
Answer
Because Desloratadine Actavis 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.
Question
What is Desloratadine Actavis?
Answer
Desloratadine Actavis is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).
Desloratadine Actavis is a ‘generic medicine’. This means that Desloratadine Actavis is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius.
Question
What is Desloratadine Actavis used for?
Answer
Desloratadine Actavis 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
Why has Desloratadine Actavis been approved?
Answer
The CHMP concluded that, in accordance with EU requirements, Desloratadine Actavis 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 Actavis be given marketing authorisation.