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 09/06/2022

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
GenericGeneric

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
13
Date of issue of marketing authorisation valid throughout the European Union
28/11/2011
Contact address

Šmarješka cesta 6
8501 Novo mesto
Slovenia

Product information

30/05/2022 Dasselta - EMEA/H/C/002310 - PSUSA/00000962/202107

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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