Stelfonta

tigilanol tiglate

Opinion

On 7 November 2019, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Stelfonta, solution for injection, intended for dogs. The applicant for this veterinary medicinal product is QBiotics Netherlands B.V. The applicant is registered as a SME pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Stelfonta is an antineoplastic medicinal product containing tigilanol tiglate (ATCvet code QL01XX91) as active substance, which activates the protein kinase C (PKC) signalling cascade, and the induction of necrosis in cells that are in direct contact with tigilanol tiglate.

The benefits of Stelfonta are its effectiveness in the treatment of non-resectable, non-metastatic (WHO staging) subcutaneous mast cell tumours, which are located at or distal to the elbow or the hock, and non-resectable, non-metastatic cutaneous mast cell tumours in dogs. The most common side effects in treated dogs are pain upon injection, and wound formation at the injection site associated with pain and lameness; as well as vomiting and tachycardia.

The appropriate CVMP guidelines on data requirements for veterinary medicinal products intended for minor use or minor species/limited markets have been applied in the assessment of the application.

The full indication is: 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.

Detailed conditions for the use of this product will be described in the summary of product characteristics (SPC) which will be published in the European public assessment report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit-risk balance for Stelfonta and therefore recommends the granting of the marketing authorisation.


1Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.

Key facts

Name
Stelfonta
Agency product number
EMEA/V/C/005018
International non-proprietary name (INN) or common name
  • tigilanol tiglate
Species
Dogs
Active substance
  • tigilanol tiglate
Date opinion adopted
07/11/2019
Company name
QBiotics Netherlands B.V.
Status
Positive
Application type
Initial authorisation

How useful was this page?

Add your rating