Jetrea

Withdrawn

This medicine's authorisation has been withdrawn

ocriplasmin

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. 

Jetrea : EPAR - Summary for the public

Reference Number: EMA/44373/2013

Product information

Jetrea : EPAR - Product Information

Jetrea : EPAR - All Authorised presentations

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002381
• Marketing authorisation holder:
  Inceptua AB

  Gustavslundsv. 143; 16751 Bromma; Sweden

• Opinion adopted:
  17/01/2013
• Marketing authorisation issued:
  13/03/2013
• Withdrawal of marketing authorisation:
  30/08/2023
• Revision:
  15

Assessment history

Changes since initial authorisation of medicine

Jetrea : EPAR - Procedural steps taken and scientific information after authorisation

Jetrea-H-C-PSUSA-00010122-201410 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/507542/2015

Initial marketing authorisation documents

Jetrea : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/74766/2013

CHMP summary of positive opinion for Jetrea

AdoptedReference Number: EMA/CHMP/5734/2013