Azomyr

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 Azomyr. 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 Azomyr.

This EPAR was last updated on 07/08/2018

Authorisation details

Product details
Name
Azomyr
Agency product number
EMEA/H/C/000310
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
Publication details
Marketing-authorisation holder
Merck Sharp Dohme B.V. 
Revision
42
Date of issue of marketing authorisation valid throughout the European Union
15/01/2001
Contact address
Merck Sharp Dohme B.V.
Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

29/06/2018 Azomyr - EMEA/H/C/000310 - T/0094

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

Azomyr is indicated for the relief of symptoms associated with:

  • allergic rhinitis;
  • urticaria.

Assessment history

Changes since initial authorisation of medicine

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