Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Finlee 10 mg dispersible tablets.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. White to slightly yellow, round, biconvex 6 mm tablet debossed with “D” on one side and “NVR” on the other. |
Each dispersible tablet contains dabrafenib mesilate equivalent to 10 mg of dabrafenib.
Excipient with known effect: Each dispersible tablet contains <0.00078 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dabrafenib |
Dabrafenib is an inhibitor of RAF kinases. Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. BRAF mutations have been identified at a high frequency in specific cancers, including approximately 50% of melanoma. Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models. |
| List of Excipients |
|---|
|
Mannitol (E421) |
Opaque white high-density polyethylene (HDPE) bottle with polypropylene child-resistant screw cap and a silica gel desiccant.
Each bottle contains 210 dispersible tablets and two 2 g desiccant canisters. Patients should be instructed to keep the desiccant canisters in the bottle and not to swallow them.
Packs containing:
Each dosing cup is 30 ml in volume with 5 ml graduated increments.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/23/1767/001-002
| Drug | Countries | |
|---|---|---|
| FINLEE | Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania |
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