Oxervate
cenegermin
Table of contents
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.
-
List item
Oxervate : EPAR - Summary for the public (PDF/75.24 KB)
First published: 25/07/2017
Last updated: 25/07/2017 -
-
List item
Oxervate : EPAR - Risk management plan summary (PDF/107.79 KB)
First published: 04/04/2022
Authorisation details
Product details | |
---|---|
Name |
Oxervate
|
Agency product number |
EMEA/H/C/004209
|
Active substance |
Recombinant human nerve growth factor
|
International non-proprietary name (INN) or common name |
cenegermin
|
Therapeutic area (MeSH) |
Keratitis
|
Anatomical therapeutic chemical (ATC) code |
S01
|
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. |
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 |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
06/07/2017
|
Contact address |
20122 Milano
Italy |
Product information
05/05/2023 Oxervate - EMEA/H/C/004209 - PSUSA/00010624/202207
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.
Pharmacotherapeutic group
Ophthalmologicals
Therapeutic indication
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults