Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Spexotras 0.05 mg/ml powder for oral solution.
| Pharmaceutical Form |
|---|
|
Powder for oral solution. White or almost white powder. |
One bottle contains trametinib dimethyl sulfoxide equivalent to 4.7 mg of trametinib.
Each ml of the reconstituted solution contains 0.05 mg of trametinib.
Excipients with known effect: Each ml of the reconstituted solution contains 100 mg of sulfobutylbetadex sodium, 0.8 mg of methyl parahydroxybenzoate and 1.98 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Trametinib |
Trametinib is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2 activation and kinase activity. In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK. Trametinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity. |
| List of Excipients |
|---|
|
Sulfobutylbetadex sodium |
Amber glass bottle of 180 ml with a child-resistant screw cap closure, containing 12 g of powder.
Each carton contains one bottle, one press-in bottle adapter and one 20 ml re-usable oral dosing syringe with 0.5 ml graduation marks.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/23/1781/001
| Drug | Countries | |
|---|---|---|
| SPEXOTRAS | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania |
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