Verkazia

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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 11/07/2019

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
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

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
2
Date of issue of marketing authorisation valid throughout the European Union
06/07/2018
Contact address
Niittyhaankatu
20 FI-33720
Tampere
Finland

Product information

04/07/2019 Verkazia - EMEA/H/C/004411 - WS/1490

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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