Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1833926
Name of medicinal product: SPHEROX
Active substances:
Autologous chondrocytes
Estonian, English, Latin
ATC code: M09AX02
Dosage form: implantation suspension
Route of administration: implantation
Strengh:  
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: eeltäidetud süstal
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 6, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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