Spherox

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spheroids of human autologous matrix-associated chondrocytes

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Spherox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Spherox.

For practical information about using Spherox, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 15/10/2018

Authorisation details

Product details
Name
Spherox
Agency product number
EMEA/H/C/002736
Active substance
spheroids of human autologous matrix-associated chondrocytes
International non-proprietary name (INN) or common name
spheroids of human autologous matrix-associated chondrocytes
Therapeutic area (MeSH)
Cartilage Diseases
Anatomical therapeutic chemical (ATC) code
M09AX02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
CO.DON AG
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
10/07/2017
Contact address
Warthestr. 21
14513 Teltow
Germany

Product information

28/06/2018 Spherox - EMEA/H/C/002736 - II/0002/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other drugs for disorders of the musculo skeletal system

Therapeutic indication

Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Repair Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.

Assessment history

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