Jetrea
Withdrawn
This medicine's authorisation has been withdrawn
ocriplasmin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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.
Product information
Latest procedure affecting product information:IA/0053
11/12/2020
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).
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
OphthalmologicalsTherapeutic 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.
News on Jetrea
Tópicos
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