Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Veterinary medicine
|
Name of medicinal product:
|
Stelfonta
|
Active substances:
|
|
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) 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
|
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
|
PƤritolumaa
|
Additional information
|
1809918
|
Stelfonta
|
solution for injection
|
1mg 1ml 2ml 1TK
|
Prescription
|
|
|
19.12.2023
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere