Jetrea
ocriplasmin
Table of contents
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.
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 |
Inceptua AB
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
13/03/2013
|
Contact address |
Gustavslundsv. 143 |
Product information
11/12/2020 Jetrea - EMEA/H/C/002381 - IA/0053
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
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.