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Product class:
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Authorized package
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Medicinal product class:
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Veterinary medicine
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Package code:
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1809918
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Name of medicinal product:
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Stelfonta
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Active substances:
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ATC code:
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QL01XX91
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Dosage form:
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solution for injection
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Route of administration:
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intratumoral use
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Strengh:
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1mg 1ml
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Amount in package:
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2ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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No
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Summary of product characteristics (SPC):
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|
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Package information leaflet (PIL):
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EST
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Labelling:
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Withdrawal time:
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Species:
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koer
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Last imported to Estonia:
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August 14, 2023
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Marketing authorization holder:
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QBiotics Netherlands B.V.
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Marketing authorization number:
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EU/2/19/248
|
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Marketing authorization issued on:
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January 15, 2020
|
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Marketing authorization expires on:
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January 17, 2025
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Marketing authorization procedure type:
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Centralised
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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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