Is Spheroids of human autologous matrix associated chondrocytes authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Spheroids of human autologous matrix associated chondrocytes: Spherox.

Is Spheroids of human autologous matrix associated chondrocytes authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Spheroids of human autologous matrix associated chondrocytes, including SPHEROX 10 70 SPHEROIDS/CM2 IMPLANTATION SUSPENSION.

Active substance

Spheroids of human autologous matrix associated chondrocytes

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Spherox CO.DON Gmbh · Authorised · authorised 10 Jul 2017 · ATC M09AX02

Therapeutic indication (EMA)

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.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
SPHEROX 10 70 SPHEROIDS/CM2 IMPLANTATION SUSPENSION	PLGB 57261/0001	CO.DON GMBH	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.