Dasselta

RSS

desloratadine

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 06/04/2018

Authorisation details

Product details
Name
Dasselta
Agency product number
EMEA/H/C/002310
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
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.

Publication details
Marketing-authorisation holder
Krka, d.d., Novo mesto
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
27/11/2011
Contact address
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

11/03/2018 Dasselta - EMEA/H/C/002310 - IB/0017

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.

Pharmacotherapeutic group

Antihistamines for systemic use

Therapeutic indication

Dasselta is indicated for the relief of symptoms associated with:

  • allergic rhinitis;
  • urticaria.

Assessment history

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