Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SPHEROX
Active substances:
Autologous chondrocytes
Estonian, English, Latin
ATC code: M09AX02
Dosage form: implantation suspension
Strength:  
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults and adolescents with closed epiphyseal growth plate in the affected joint.
Safety features: Yes
Marketing authorization holder: Rejuvenate GmbH 
Marketing authorization number: EU/1/17/1181 
Marketing authorization issued on: July 10, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1749775  SPHEROX  implantation suspension  1TK  Prescription           
1833926  SPHEROX  implantation suspension  1TK  Prescription          eeltäidetud süstal 
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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