Dasselta

desloratadine

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

What is Dasselta?

Dasselta is a medicine containing the active substance desloratadine. It is available as tablets (5 mg).

Dasselta is a ‘generic medicine’. This means that Dasselta is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Aerius.

What is Dasselta used for?

Dasselta 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 Dasselta used?

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

How does Dasselta work?

The active substance in Dasselta, 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 Dasselta been studied?

Because Dasselta 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 Dasselta?

Because Dasselta 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 Dasselta been approved?

The CHMP concluded that, in accordance with EU requirements, Dasselta 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 Dasselta be given marketing authorisation.

Other information about Dasselta

The European Commission granted a marketing authorisation valid throughout the European Union for Dasselta on 28 November 2011.

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

Name Language First published Last updated
Dasselta : EPAR - Summary for the public BG = bălgarski 2011-12-15  
Dasselta : EPAR - Summary for the public ES = español 2011-12-15  
Dasselta : EPAR - Summary for the public CS = čeština 2011-12-15  
Dasselta : EPAR - Summary for the public DA = dansk 2011-12-15  
Dasselta : EPAR - Summary for the public DE = Deutsch 2011-12-15  
Dasselta : EPAR - Summary for the public ET = eesti keel 2011-12-15  
Dasselta : EPAR - Summary for the public EL = elliniká 2011-12-15  
Dasselta : EPAR - Summary for the public EN = English 2011-12-15  
Dasselta : EPAR - Summary for the public FR = français 2011-12-15  
Dasselta : EPAR - Summary for the public IT = italiano 2011-12-15  
Dasselta : EPAR - Summary for the public LT = lietuvių kalba 2011-12-15  
Dasselta : EPAR - Summary for the public HU = magyar 2011-12-15  
Dasselta : EPAR - Summary for the public MT = Malti 2011-12-15  
Dasselta : EPAR - Summary for the public NL = Nederlands 2011-12-15  
Dasselta : EPAR - Summary for the public PL = polski 2011-12-15  
Dasselta : EPAR - Summary for the public PT = português 2011-12-15  
Dasselta : EPAR - Summary for the public RO = română 2011-12-15  
Dasselta : EPAR - Summary for the public SK = slovenčina 2011-12-15  
Dasselta : EPAR - Summary for the public SL = slovenščina 2011-12-15  
Dasselta : EPAR - Summary for the public FI = suomi 2011-12-15  
Dasselta : EPAR - Summary for the public SV = svenska 2011-12-15  

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

Authorisation details

Product details

Product details for Dasselta
NameDasselta
Agency product numberEMEA/H/C/002310
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 Dasselta
Marketing-authorisation holder

Krka, d.d., Novo mesto

Revision10
Date of issue of marketing authorisation valid throughout the European Union28/11/2011

Contact address:

Krka, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

Product information

12/03/2018  Dasselta -EMEA/H/C/002310 -IB/0017

Name Language First published Last updated
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 2018-04-06
Dasselta : EPAR - Product Information SV = svenska 2011-12-15 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
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  
Dasselta : EPAR - All Authorised presentations SV = svenska 2011-12-15  

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Dasselta 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
Dasselta : EPAR - Public assessment report SV = svenska 2011-12-15  
CHMP summary of positive opinion for Dasselta SV = svenska 2011-09-23  

Authorised

This medicine is approved for use in the European Union

More information on Dasselta