Dasselta

Authorised

This medicine is authorised for use in the European Union

desloratadine

Overview

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.

Dasselta : EPAR - Summary for the public

Reference Number: EMA/828337/2011

Product information

Dasselta : EPAR - Product Information

Latest procedure affecting product information: PSUSA/00000962/202107

30/05/2022

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Dasselta : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Dasselta
• Active substance:
  desloratadine
• International non-proprietary name (INN) or common name:
  desloratadine
• Therapeutic area (MeSH):
  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Seasonal
  • Urticaria
• Anatomical therapeutic chemical (ATC) code:
  R06AX27

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Dasselta is indicated for the relief of symptoms associated with:

• allergic rhinitis;
• urticaria.

Authorisation details

• EMA product number:
  EMEA/H/C/002310
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Krka, d.d., Novo mesto

  Šmarješka cesta 6; 8501 Novo mesto; Slovenia

• Marketing authorisation issued:
  28/11/2011
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Dasselta : EPAR - Procedural steps taken and scientific information after authorisation

Dasselta-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/567651/2022

Dasselta-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/333803/2017

Initial marketing authorisation documents

Dasselta : EPAR - Public assessment report

AdoptedReference Number: EMA/895265/2011

CHMP summary of positive opinion for Dasselta

AdoptedReference Number: EMA/CHMP/614045/2011