Spherox

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spheroids of human autologous matrix-associated chondrocytes

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

Overview

Spherox is a medicine used to repair defects to the cartilage in the knee in adults who are experiencing
symptoms (such as pain and problems moving the knee). It is used where the affected area is no
larger than 10 cm².

Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage,
that have been prepared from the patient’s own tissues.

This EPAR was last updated on 29/06/2020

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
4
Date of issue of marketing authorisation valid throughout the European Union
10/07/2017
Contact address
Warthestr. 21
14513 Teltow
Germany

Product information

28/05/2020 Spherox - EMEA/H/C/002736 - II/0015

Contents

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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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