Avamys

RSS

fluticasone furoate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 14/05/2019

Authorisation details

Product details
Name
Avamys
Agency product number
EMEA/H/C/000770
Active substance
fluticasone furoate
International non-proprietary name (INN) or common name
fluticasone furoate
Therapeutic area (MeSH)
  • Rhinitis, Allergic, Seasonal
  • Rhinitis, Allergic, Perennial
Anatomical therapeutic chemical (ATC) code
R01AD12
Publication details
Marketing-authorisation holder
GlaxoSmithKline (Ireland) Limited
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
11/01/2008
Contact address

12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Product information

06/12/2018 Avamys - EMEA/H/C/000770 - T/0037

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

  • NASAL PREPARATIONS
  • Corticosteroids

Therapeutic indication

Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.

Assessment history

How useful was this page?

Add your rating
Average
1 rating