Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
Name of medicinal product: Stelfonta
Active substances:
Tigilanol tiglate
Estonian, English, Latin
ATC code: QL01XX91
Dosage form: solution for injection
Strength: 1mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: For the treatment of non-resectable, non-metastatic (WHO staging) subcutaneous mast cell tumours located at or distal to the elbow or the hock, and non-resectable, non-metastatic cutaneous mast cell tumours in dogs. Tumours must be less than or equal to 8 cm3 in volume, and must be accessible to intratumoral injection.
Safety features: No
Marketing authorization holder: QBiotics Netherlands B.V. 
Marketing authorization number: EU/2/19/248 
Marketing authorization issued on: January 15, 2020 
Marketing authorization expires on: January 17, 2025 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1809918  Stelfonta  solution for injection  1mg 1ml 2ml 1TK  Prescription      05.11.2021   
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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