Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: Veterinary medicine
Package code: 1809918
Name of medicinal product: Stelfonta
Active substances:
Tigilanol tiglate
Estonian, English, Latin
ATC code: QL01XX91
Dosage form: solution for injection
Route of administration: intratumoral use
Strengh: 1mg 1ml
Amount in package: 2ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For the treatment of non-resectable, non-metastatic (WHO staging) mast cell tumours of the following types in dogs: - Cutaneous mast cell tumours (located anywhere on the dog), and - Subcutaneous mast cell tumours located at or distal to the elbow or the hock Tumours must be less than or equal to 8 cm3 in volume, and must be accessible to intratumoral injection.
Safety features: No
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Withdrawal time:  
Species: koer
Last imported to Estonia: April 8, 2024
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 
Entry/Changing date: September 15, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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