Verkazia

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 Verkazia. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.

It is not intended to provide practical advice on how to use Verkazia.

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

This EPAR was last updated on 25/04/2019

Authorisation details

Product details
Name
Verkazia
Agency product number
EMEA/H/C/004411
Active substance
ciclosporin
International non-proprietary name (INN) or common name
ciclosporin
Therapeutic area (MeSH)
  • Conjunctivitis
  • Keratitis
Anatomical therapeutic chemical (ATC) code
S01XA18
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Santen Oy
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
06/07/2018
Contact address
Niittyhaankatu
20 FI-33720
Tampere
Finland

Product information

25/03/2019 Verkazia - EMEA/H/C/004411 - N/0004

Contents

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Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.

Assessment history

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