Table of contents
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.
Oxervate : EPAR - Summary for the public (PDF/75.24 KB)
First published: 25/07/2017
Last updated: 25/07/2017
Oxervate : EPAR - Risk management plan summary (PDF/107.79 KB)
First published: 04/04/2022
|Agency product number||
Recombinant human nerve growth factor
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
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.
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.
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.
Dompe farmaceutici s.p.a.
|Date of issue of marketing authorisation valid throughout the European Union||
28/03/2022 Oxervate - EMEA/H/C/004209 - R/0037
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults