Oxervate

RSS

cenegermin

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

Overview

This is a summary of the European public assessment report (EPAR) for Oxervate. 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 Oxervate.

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

This EPAR was last updated on 25/07/2017

Authorisation details

Product details
Name
Oxervate
Agency product number
EMEA/H/C/004209
Active substance
recombinant human Nerve Growth factor (rhNGF)
International non-proprietary name (INN) or common name
cenegermin
Therapeutic area (MeSH)
Keratitis
Anatomical therapeutic chemical (ATC) code
S01
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Marketing-authorisation holder
Dompe farmaceutici s.p.a.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
06/07/2017
Contact address
20122 Milano
Italy

Product information

06/07/2017 Oxervate - EMEA/H/C/004209 -

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 moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults

Assessment history

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