Jetrea

RSS

ocriplasmin

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

Overview

This is a summary of the European public assessment report (EPAR) for Jetrea. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Jetrea.

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

This EPAR was last updated on 06/09/2018

Authorisation details

Product details
Name
Jetrea
Agency product number
EMEA/H/C/002381
Active substance
ocriplasmin
International non-proprietary name (INN) or common name
ocriplasmin
Therapeutic area (MeSH)
Retinal Diseases
Anatomical therapeutic chemical (ATC) code
S01XA22
Publication details
Marketing-authorisation holder
ThromboGenics NV
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
12/03/2013
Contact address
Gaston Geenslaan 1
B-3001 Leuven
Belgium

Product information

30/07/2018 Jetrea - EMEA/H/C/002381 - IB/0040/G

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

Jetrea is indicated in adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Assessment history

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