Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Voranigo 10 mg film-coated tablets.
Voranigo 40 mg film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet. Voranigo 10 mg film-coated tablets: White to off-white, round tablets with a 6 mm diameter, imprinted with '10' on one side. Voranigo 40 mg film-coated tablets: White to off-white, oblong tablets with a length of 14.8 mm and width of 6.3 mm, imprinted with '40' on one side. |
Each film-coated tablet contains 10 mg of vorasidenib (as hemicitric acid, hemihydrate).
Excipient with known effect: Each film-coated tablet contains lactose monohydrate, equivalent to 0.60 mg lactose (see section 4.4).
Each film-coated tablet contains 40 mg of vorasidenib (as hemicitric acid, hemihydrate).
Excipient with known effect: Each film-coated tablet contains lactose monohydrate, equivalent to 2.39 mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Vorasidenib is an inhibitor that targets the mutant IDH1 and IDH2 enzymes. In patients with astrocytoma or oligodendroglioma, IDH1 and IDH2 mutations lead to overproduction of the oncogenic metabolite 2-hydroxyglutarate (2-HG), resulting in impaired cellular differentiation contributing to oncogenesis. Inhibition of the IDH1- and IDH2-mutated proteins by vorasidenib inhibits the abnormal production of 2-HG leading to differentiation of malignant cells and a reduction in their proliferation. |
| List of Excipients |
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Tablet core: Microcrystalline cellulose (E460) Tablet film-coating: Hypromellose Printing ink: Black iron oxide (E172) |
White HDPE bottle with a polypropylene (PP) child-resistant closure and polyethylene (PE) faced induction heat seal liner including three silica gel desiccants in HDPE canisters. Pack-size of 30 film-coated tablets.
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
EU/1/25/1912/001
EU/1/25/1912/002
| Drug | Countries | |
|---|---|---|
| VORANIGO | Austria, Estonia, Lithuania, United Kingdom, United States |
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