Oxervate

cenegermin

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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.

What is Oxervate and what is it used for?

Oxervate is a medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally.

The medicine is only used in adults with moderate or severe disease.

Because the number of patients with neurotrophic keratitis is low, the disease is considered ‘rare’, and Oxervate was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 14 December 2015.

Oxervate contains the active substance cenegermin.

How is Oxervate used?

Oxervate is available as eye drops. The recommended dose is 1 drop in the affected eye every 2 hours, 6 times per day. Treatment should continue for 8 weeks.

Oxervate can only be obtained with a prescription and treatment should be started and supervised by an eye specialist.

For further information, see the package leaflet.

How does Oxervate work?

Patients with neurotrophic keratitis have lower than normal levels of substances including growth factors that are normally supplied by the trigeminal nerve and which play an important role in the growth and survival of the cells of the eye’s surface. The active substance in Oxervate, cenegermin, is a copy of a human growth factor called nerve growth factor. When given as eye drops to patients with neurotrophic keratitis, cenegermin helps restore some of the normal healing processes in the eye and repair damage to the eye’s surface associated with the condition.

What benefits of Oxervate have been shown in studies?

Oxervate has been shown to help heal damage to the eye’s surface in 2 main studies involving a total of 204 adults with moderate or severe neurotrophic keratitis. In the first study, 74% (37 out of 50) of patients treated with Oxervate for 8 weeks achieved complete healing of the eye’s surface compared with 43% (22 out of 51) of patients treated with a dummy treatment containing the same eye drop formula but no active substance. In the second study, figures were 70% (16 out of 23) with Oxervate and 29% (7 out of 24) with the dummy treatment.

What are the risks associated with Oxervate?

The most common side effects with Oxervate (which may affect more than 1 in 100 people) are eye pain and inflammation, increased lacrimation (watery eyes), pain in the eyelid and sensation of a foreign body in the eye.

For the full list of all side effects and restrictions with Oxervate, see the package leaflet.

Why is Oxervate approved?

Oxervate has been shown to increase by around 30-40% the number of patients who achieve complete healing of the eye’s surface when compared with eye drops containing no active substance. Side effects with Oxervate are mainly related to the eye, are mild or moderate in severity and resolve over time.

The European Medicines Agency therefore decided that Oxervate’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Oxervate?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oxervate have been included in the summary of product characteristics and the package leaflet.

Other information

The European Commission granted a marketing authorisation valid throughout the European Union for Oxervate on 06 July 2017. For more information about treatment with Oxervate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Oxervate : EPAR - Summary for the public BG = bălgarski 2017-07-25  
Oxervate : EPAR - Summary for the public ES = español 2017-07-25  
Oxervate : EPAR - Summary for the public CS = čeština 2017-07-25  
Oxervate : EPAR - Summary for the public DA = dansk 2017-07-25  
Oxervate : EPAR - Summary for the public DE = Deutsch 2017-07-25  
Oxervate : EPAR - Summary for the public ET = eesti keel 2017-07-25  
Oxervate : EPAR - Summary for the public EL = elliniká 2017-07-25  
Oxervate : EPAR - Summary for the public EN = English 2017-07-25  
Oxervate : EPAR - Summary for the public FR = français 2017-07-25  
Oxervate : EPAR - Summary for the public IT = italiano 2017-07-25  
Oxervate : EPAR - Summary for the public LV = latviešu valoda 2017-07-25  
Oxervate : EPAR - Summary for the public LT = lietuvių kalba 2017-07-25  
Oxervate : EPAR - Summary for the public HU = magyar 2017-07-25  
Oxervate : EPAR - Summary for the public MT = Malti 2017-07-25  
Oxervate : EPAR - Summary for the public NL = Nederlands 2017-07-25  
Oxervate : EPAR - Summary for the public PL = polski 2017-07-25  
Oxervate : EPAR - Summary for the public PT = português 2017-07-25  
Oxervate : EPAR - Summary for the public RO = română 2017-07-25  
Oxervate : EPAR - Summary for the public SK = slovenčina 2017-07-25  
Oxervate : EPAR - Summary for the public SL = slovenščina 2017-07-25  
Oxervate : EPAR - Summary for the public FI = suomi 2017-07-25  
Oxervate : EPAR - Summary for the public SV = svenska 2017-07-25  
Oxervate : EPAR - Summary for the public HR = Hrvatski 2017-07-25  

This EPAR was last updated on 25/07/2017 .

Authorisation details

Product details

Product details for Oxervate
NameOxervate
Agency product numberEMEA/H/C/004209
Active substance

recombinant human Nerve Growth factor (rhNGF)

International non-proprietary name (INN) or common name

cenegermin

Therapeutic area Keratitis
Anatomical therapeutic chemical (ATC) code S01
Additional monitoring

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

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Oxervate
Marketing-authorisation holder

Dompe farmaceutici s.p.a.

Revision0
Date of issue of marketing authorisation valid throughout the European Union06/07/2017

Contact address:

Dompe farmaceutici s.p.a.
20122 Milano 
Italy
 

Product information

Product information

06/07/2017  Oxervate -EMEA/H/C/004209

Name Language First published Last updated
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  
Oxervate : EPAR - Product Information HR = Hrvatski 2017-07-25  

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.


Name Language First published Last updated
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  
Oxervate : EPAR - All Authorised presentations HR = Hrvatski 2017-07-25  

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Oxervate : EPAR - Public assessment report HR = Hrvatski 2017-07-25  
CHMP summary of positive opinion for Oxervate HR = Hrvatski 2017-05-19  

Authorised

This medicine is approved for use in the European Union

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