JETREA Concentrate for solution for injection Ref.[9656] Active ingredients: Ocriplasmin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Oxurion NV, Gaston Geenslaan 1, B-3001, Leuven, Belgium

Product name and form

JETREA 0.5 mg/0.2 mL concentrate for solution for injection.

Pharmaceutical Form

Concentrate for solution for injection (sterile concentrate).

Clear and colourless solution.

Qualitative and quantitative composition

Each vial contains 0.5 mg of ocriplasmin* in 0.2 mL solution.

After dilution with 0.2 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, 0.1 mL of the diluted solution contains 0.125 mg ocriplasmin.

* Ocriplasmin is a truncated form of human plasmin produced by recombinant DNA technology in a Pichia pastoris expression system.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ocriplasmin

Ocriplasmin has a proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI) (e.g. laminin, fibronectin and collagen) and aims to dissolve the protein matrix responsible for the abnormal vitreomacular adhesion (VMA).

List of Excipients

Mannitol
Citric acid
Sodium hydroxide (NaOH) (for pH adjustment)
Water for injections

Pack sizes and marketing

0.2 mL solution in a vial (type I glass) closed with a chlorobutyl rubber stopper and an orange polypropylene flip-off cap. Pack containing 1 vial.

Marketing authorization holder

Oxurion NV, Gaston Geenslaan 1, B-3001, Leuven, Belgium

Marketing authorization dates and numbers

EU/1/13/819/001

Date of first authorisation: 13 March 2013
Date of latest renewal: 8 December 2017

Drugs

Drug Countries
JETREA Austria, Australia, Cyprus, Estonia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States

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