Emadine

RSS

emedastine

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 their 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 07/05/2018

Authorisation details

Product details
Name
Emadine
Agency product number
EMEA/H/C/000223
Active substance
emedastine
International non-proprietary name (INN) or common name
emedastine
Therapeutic area (MeSH)
Conjunctivitis, Allergic
Anatomical therapeutic chemical (ATC) code
S01GX06
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
27/01/1999
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

23/04/2018 Emadine - EMEA/H/C/000223 - T/0046

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

OPHTHALMOLOGICALS

Therapeutic indication

Symptomatic treatment of seasonal allergic conjunctivitis.

Assessment history

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