Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Tibsovo 250 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Blue, oval shaped, film-coated tablets approximately 18 mm in length, debossed with ‘IVO’ on one side and ‘250’ on the other side. |
Each film-coated tablet contains 250 mg of ivosidenib.
Excipient with known effect: Each film-coated tablet contains lactose monohydrate equivalent to 9.5 mg lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ivosidenib |
Ivosidenib is an inhibitor of the mutant IDH1 enzyme. Mutant IDH1 converts alpha- ketoglutarate (αKG) to 2-hydroxyglutarate (2-HG) which blocks cellular differentiation and promotes tumorigenesis in both hematologic and non-hematologic malignancies. The mechanism of action of ivosidenib beyond its ability to reduce 2-HG and restore cellular differentiation is not fully understood across indications. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Hypromellose |
High density polyethylene (HDPE) bottle with polypropylene (PP) child resistant closure and polyethylene (PE) faced induction heat seal liner. Each bottle contains 60 film-coated tablets and a silica gel desiccant in a HDPE canister.
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
EU/1/23/1728/001
Date of first authorisation: 04 May 2023
| Drug | Countries | |
|---|---|---|
| TIBSOVO | Austria, Cyprus, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Romania, United Kingdom, United States |
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