Jetrea | European Medicines Agency (EMA)

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Overview

On 30 August 2023, the European Commission withdrew the marketing authorisation for Jetrea (ocriplasmin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Inceptua AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Jetrea was granted marketing authorisation in the EU on 13 March 2013 for the treatment of vitreomacular traction. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2017. 

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čeština (CS)
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dansk (DA)
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Deutsch (DE)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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Product information

English (EN)
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български (BG)
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First published: 18/04/2013Last updated: 19/06/2025

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español (ES)
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čeština (CS)
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dansk (DA)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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norsk (NO)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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Latest procedure affecting product information:
IA/0053

11/12/2020

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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).

English (EN)
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български (BG)
(91 KB – PDF)

First published: 18/04/2013Last updated: 19/06/2025

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español (ES)
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First published: 18/04/2013Last updated: 19/06/2025

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čeština (CS)
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First published: 18/04/2013Last updated: 19/06/2025

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dansk (DA)
(80.82 KB – PDF)

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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
(88.79 KB – PDF)

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français (FR)
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hrvatski (HR)
(84.61 KB – PDF)

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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
(83.28 KB – PDF)

First published: 18/04/2013Last updated: 19/06/2025

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lietuvių kalba (LT)
(83.5 KB – PDF)

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magyar (HU)
(82.72 KB – PDF)

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Malti (MT)
(88.97 KB – PDF)

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Nederlands (NL)
(80.45 KB – PDF)

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norsk (NO)
(78.91 KB – PDF)

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polski (PL)
(88.79 KB – PDF)

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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
(79.05 KB – PDF)

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Suomi (FI)
(78.74 KB – PDF)

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svenska (SV)
(80.05 KB – PDF)

First published: 18/04/2013Last updated: 19/06/2025

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Product details

Name of medicine

Jetrea

Active substance

ocriplasmin

International non-proprietary name (INN) or common name

ocriplasmin

Therapeutic area (MeSH)

Retinal Diseases

Anatomical therapeutic chemical (ATC) code

S01XA22

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.

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