Ikervis

RSS

ciclosporin

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

Overview

This is a summary of the European public assessment report (EPAR) for Ikervis. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union and its conditions of use. It is not intended to provide practical advice on how to use Ikervis.

For practical information about using Ikervis, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 03/02/2017

Authorisation details

Product details
Name
Ikervis
Agency product number
EMEA/H/C/002066
Active substance
ciclosporin
International non-proprietary name (INN) or common name
ciclosporin
Therapeutic area (MeSH)
Corneal Diseases
Anatomical therapeutic chemical (ATC) code
S01XA18
Publication details
Marketing-authorisation holder
Santen Oy
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
19/03/2015
Contact address
Niittyhaankatu
20 FI-33720
Tampere
Finland

Product information

09/01/2017 Ikervis - EMEA/H/C/002066 - IAIN/08/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.

Assessment history

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