Verkazia
ciclosporin
Table of contents
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.
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List item
Verkazia : EPAR - Summary for the public (PDF/76.1 KB)
First published: 12/07/2018
Last updated: 12/07/2018
EMA/476178/2017 -
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List item
Verkazia : EPAR - Risk-management-plan summary (PDF/28.93 KB)
First published: 10/07/2020
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) |
|
Anatomical therapeutic chemical (ATC) code |
S01XA18
|
Accelerated 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
Santen Oy
|
Revision |
4
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Date of issue of marketing authorisation valid throughout the European Union |
06/07/2018
|
Contact address |
Product information
15/04/2020 Verkazia - EMEA/H/C/004411 - IB/0009
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
Treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents.