Desloratadine Actavis

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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 Desloratadine Actavis. 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 Actavis.

This EPAR was last updated on 06/04/2018

Authorisation details

Product details
Name
Desloratadine Actavis
Agency product number
EMEA/H/C/002435
Active substance
desloratadine
International non-proprietary name (INN) or common name
desloratadine
Therapeutic area (MeSH)
  • Rhinitis, Allergic, Perennial
  • Urticaria
  • Rhinitis, Allergic, Seasonal
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 medicines.

Publication details
Marketing-authorisation holder
Actavis Group PTC ehf
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
13/01/2012
Contact address
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

21/03/2018 Desloratadine Actavis - EMEA/H/C/002435 - N/0014

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

Treatment of allergic rhinitis and urticaria.

Assessment history

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