Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
TEPMETKO 225 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). White-pink, oval, biconvex film-coated tablet of approximately 18 × 9 mm in size, embossed with ‘M’ on one side and plain on the other side. |
Each film-coated tablet contains 225 mg tepotinib (as hydrochloride hydrate).
Excipient with known effect: Each film-coated tablet contains 4.4 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tepotinib |
Tepotinib is a reversible Type I adenosine triphosphate (ATP)-competitive small molecule inhibitor of MET. Tepotinib blocked MET phosphorylation and MET-dependent downstream signalling in a dose-dependent manner. Tepotinib demonstrated pronounced anti-tumour activity in tumours with oncogenic activation of MET, such as METex14 skipping alterations. |
| List of Excipients |
|---|
|
Tablet core: Mannitol Film-coating: Hypromellose |
Aluminium/Polyvinyl chloride-polyethylene-polyvinylidene chloride-polyethylene-polyvinyl chloride (Al/PVC-PE-PVDC-PE-PVC) blister. Pack of 60 film-coated tablets.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/21/1596/001
| Drug | Countries | |
|---|---|---|
| TEPMETKO | Austria, Brazil, Estonia, Finland, Croatia, Israel, Italy, Japan, Lithuania, Poland, United States |
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