Desloratadine Actavis

desloratadine

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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.

What is Desloratadine Actavis?

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.

What is Desloratadine Actavis used for?

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.

How is Desloratadine Actavis used?

The recommended dose for adults and adolescents (12 years of age and over) is 5 mg once a day.

How does Desloratadine Actavis work?

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.

How has Desloratadine Actavis been studied?

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.

What are the benefits and risks of Desloratadine Actavis?

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.

Why has Desloratadine Actavis been approved?

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.

Other information about Desloratadine Actavis

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.

Name Language First published Last updated
Desloratadine Actavis : EPAR - Summary for the public BG = bălgarski 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public ES = español 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public CS = čeština 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public DA = dansk 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public DE = Deutsch 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public ET = eesti keel 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public EL = elliniká 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public EN = English 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public FR = français 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public IT = italiano 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public LV = latviešu valoda 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public LT = lietuvių kalba 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public HU = magyar 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public MT = Malti 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public NL = Nederlands 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public PL = polski 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public PT = português 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public RO = română 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public SK = slovenčina 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public SL = slovenščina 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public FI = suomi 2012-01-25  
Desloratadine Actavis : EPAR - Summary for the public SV = svenska 2012-01-25  

This EPAR was last updated on 06/04/2018 .

Authorisation details

Product details

Product details for Desloratadine Actavis
NameDesloratadine Actavis
Agency product numberEMEA/H/C/002435
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
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Desloratadine Actavis
Marketing-authorisation holder

Actavis Group PTC ehf

Revision10
Date of issue of marketing authorisation valid throughout the European Union13/01/2012

Contact address:

Actavis Group PTC ehf
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

Product information

21/03/2018  Desloratadine Actavis -EMEA/H/C/002435 -N/0014

Name Language First published Last updated
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06
Desloratadine Actavis : EPAR - Product Information SV = svenska 2012-01-25 2018-04-06

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
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19
Desloratadine Actavis : EPAR - All Authorised presentations SV = svenska 2012-01-25 2014-03-19

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Treatment of allergic rhinitis and urticaria.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Desloratadine Actavis : EPAR - Public assessment report SV = svenska 2012-01-25  
CHMP summary of positive opinion for Desloratadine Actavis SV = svenska 2011-11-18  

Authorised

This medicine is approved for use in the European Union

More information on Desloratadine Actavis