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🇪🇺EU · EMAAuthorisedATC: L01EC02Orphan Medicine

Finlee(dabrafenib mesilate)

Glioma

Marketing Authorisation Holder: Novartis Europharm Limited

EMA Authorisation: 15/11/2023

INN: dabrafenib

Indication

Low-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. High-grade glioma Finlee in combination with trametinib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.