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PRODUCT DETAIL

Tibsovo 250 mg filmom obalené tablety

Code 3596E
MA number EU/1/23/1728/001
Product Form: tbl flm 60x250 mg (fľ.HDPE)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
MAH, country: Les Laboratoires Servier, France
Therapeutic Class: 44 - CYTOSTATICA
ATC:
L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L01 ANTINEOPLASTIC AGENTS
L01X OTHER ANTINEOPLASTIC AGENTS
L01XX Other antineoplastic agents
L01XX62 Ivosidenib
Shelf life: 48
Container: bottle HDPE
Route of admin.: Oral use
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 04.05.2023
Validity: 04.05.2028
SmPC + PL: European Medicines Agency's database
Dokument: Tibsovo_karta pacienta.pdf  
Safety feature Yes
Data update: 17.05.2023
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