Spherox
spheroids of human autologous matrix-associated chondrocytes
Table of contents
Overview
Spherox is a medicine used to repair defects to the cartilage in the knee in patients 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 is used in adults and in adolescents whose bones in the joints have finished growing.
Spherox contains spheroids (spherical aggregates) of chondrocytes, cells found in healthy cartilage, that have been prepared from the patient’s own tissues.
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Spherox : EPAR - Summary for the public (PDF/118.4 KB)
First published: 24/07/2017
Last updated: 14/07/2021
EMA/315758/2020 -
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Spherox : EPAR - Risk-management-plan summary (PDF/226.53 KB)
First published: 24/07/2017
Last updated: 22/08/2022
Authorisation details
Product details | |
---|---|
Name |
Spherox
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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
|
Publication details | |
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Marketing-authorisation holder |
CO.DON Gmbh
|
Revision |
8
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Date of issue of marketing authorisation valid throughout the European Union |
10/07/2017
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Contact address |
Deutscher Platz 5d |
Product information
16/02/2023 Spherox - EMEA/H/C/002736 - IAIN/0031/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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.