Desloratadine Teva

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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 Teva. 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 Teva.

This EPAR was last updated on 23/05/2018

Authorisation details

Product details
Name
Desloratadine Teva
Agency product number
EMEA/H/C/002419
Active substance
desloratadine
International non-proprietary name (INN) or common name
desloratadine
Therapeutic area (MeSH)
  • Rhinitis, Allergic, Perennial
  • 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
Teva B.V
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
24/11/2011
Contact address
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

13/03/2018 Desloratadine Teva - EMEA/H/C/002419 - N/0020

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

Desloratadine Teva is indicated for the relief of symptoms associated with:

  • allergic rhinitis;
  • urticaria.

Assessment history

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