Desloratadine Teva

desloratadine

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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.

What is Desloratadine Teva?

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.

What is Desloratadine Teva used for?

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.

How is Desloratadine Teva used?

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

How does Desloratadine Teva work?

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.

How has Desloratadine Teva been studied?

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.

What are the benefits and risks of Desloratadine Teva?

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.

Why has Desloratadine Teva been approved?

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.

Other information about Desloratadine Teva

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.

Name Language First published Last updated
Desloratadine Teva : EPAR - Summary for the public BG = bălgarski 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public ES = español 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public CS = čeština 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public DA = dansk 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public DE = Deutsch 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public ET = eesti keel 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public EL = elliniká 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public EN = English 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public FR = français 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public IT = italiano 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public LV = latviešu valoda 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public LT = lietuvių kalba 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public HU = magyar 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public MT = Malti 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public NL = Nederlands 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public PL = polski 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public PT = português 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public RO = română 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public SK = slovenčina 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public SL = slovenščina 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public FI = suomi 2011-12-08  
Desloratadine Teva : EPAR - Summary for the public SV = svenska 2011-12-08  

This EPAR was last updated on 06/02/2018 .

Authorisation details

Product details

Product details for Desloratadine Teva
NameDesloratadine Teva
Agency product numberEMEA/H/C/002419
Active substance

desloratadine

International non-proprietary name (INN) or common name

desloratadine

Therapeutic area Rhinitis, 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 Teva
Marketing-authorisation holder

Teva B.V

Revision11
Date of issue of marketing authorisation valid throughout the European Union24/11/2011

Contact address:

Teva B.V
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

17/01/2018  Desloratadine Teva -EMEA/H/C/002419 -IB/0019

Name Language First published Last updated
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06
Desloratadine Teva : EPAR - Product Information SV = svenska 2011-12-08 2018-02-06

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 Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19
Desloratadine Teva : EPAR - All Authorised presentations SV = svenska 2011-12-08 2015-10-19

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Desloratadine Teva 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
Desloratadine Teva : EPAR - Public assessment report SV = svenska 2011-12-08  
CHMP summary of positive opinion for Desloratadine Teva SV = svenska 2011-09-23  

Authorised

This medicine is approved for use in the European Union

More information on Desloratadine Teva