Aerius

desloratadine

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This is a summary of the European public assessment report (EPAR) for Aerius. 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 Aerius.

What is Aerius?

Aerius is a medicine containing the active substance desloratadine. It is available as a 5-mg tablet, a 5-mg oral lyophilisate (dispersible tablet), 2.5-mg and 5-mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5-mg/ml syrup and a 0.5-mg/ml oral solution.

What is Aerius used for?

Aerius 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 Aerius used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day. The dose in children depends on their age. For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution. For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5-mg orodispersible tablet. Adults and adolescents can use any form of the medicine.

How does Aerius work?

The active substance in Aerius, 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 Aerius been studied?

Aerius has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma). The effectiveness of Aerius was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.

Aerius has also been studied in 416 patients with urticaria. The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.

In all studies, the effectiveness of Aerius was compared with that of placebo (a dummy treatment).

Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.

What benefit has Aerius shown during the studies?

In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Aerius led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo. In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Aerius was 58 and 67%, compared with 40 and 33% in placebo-treated patients.

What is the risk associated with Aerius?

In adults and adolescents, the most common side effects are fatigue (tiredness; 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects seen in children are similar. In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%). For the full list of all side effects reported with Aerius, see the package leaflet.

Aerius must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.

Why has Aerius been approved?

The CHMP decided that Aerius’s benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.

Other information about Aerius

The European Commission granted a marketing authorisation valid throughout the European Union for Aerius on 15 January 2001.

For more information about treatment with Aerius, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Aerius : EPAR - Summary for the public BG = bălgarski 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public ES = español 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public CS = čeština 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public DA = dansk 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public DE = Deutsch 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public ET = eesti keel 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public EL = elliniká 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public EN = English 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public FR = français 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public IT = italiano 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public LV = latviešu valoda 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public LT = lietuvių kalba 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public HU = magyar 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public MT = Malti 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public NL = Nederlands 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public PL = polski 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public PT = português 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public RO = română 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public SK = slovenčina 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public SL = slovenščina 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public FI = suomi 19/06/2008 23/11/2011
Aerius : EPAR - Summary for the public SV = svenska 19/06/2008 23/11/2011

This EPAR was last updated on 09/10/2013 .

Authorisation details

Product details

Product details for Aerius
NameAerius
Agency product numberEMEA/H/C/000313
Active substance

desloratadine

International non-proprietary name (INN) or common name

desloratadine

Therapeutic area UrticariaRhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial
Anatomical therapeutic chemical (ATC) code R06AX27

Publication details

Publication details for Aerius
Marketing-authorisation holder

Merck Sharp & Dohme Ltd.

Revision28
Date of issue of marketing authorisation valid throughout the European Union15/01/2001

Contact address:

Merck Sharp & Dohme Ltd.
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

13/09/2013  Aerius -EMEA/H/C/000313 -IB/0066

Name Language First published Last updated
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013
Aerius : EPAR - Product Information SV = svenska 26/06/2009 09/10/2013

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012
Aerius : EPAR - All Authorised presentations SV = svenska 31/08/2007 26/09/2012

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Aerius is indicated for the relief of symptoms associated with:

  • allergic rhinitis;
  • urticaria.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Aerius : EPAR - Procedural steps taken before authorisation SV = svenska 03/04/2006  
Aerius : EPAR - Scientific Discussion SV = svenska 03/04/2006  

Authorised

This medicine is approved for use in the European Union