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 02/08/2023

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
N.V. Organon
Revision
52
Date of issue of marketing authorisation valid throughout the European Union
15/01/2001
Contact address

Kloosterstraat 6
5349 AB Oss
The Netherlands

Product information

08/06/2023 Azomyr - EMEA/H/C/000310 - WS/2464

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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

Azomyr is indicated for the relief of symptoms associated with:

  • allergic rhinitis (see section 5.1)
  • urticaria (see section 5.1)

Assessment history

Changes since initial authorisation of medicine

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