Tibsovo

Medicinal product

(Invented) name

Tibsovo

Active substance (s)

Ivosidenibas

Strength

250 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XM02, ivosidenib

Marketing authorisation holder

Les Laboratoires Servier, Prancūzija

Date of authorisation

2023-05-04

Date of renewal

Documents

Tibsovo paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Film-coated tablet	1 vnt.
Ivosidenibas	250 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
110983	97094	1097094	buteliukas	N60		Receptinis	EU/1/23/1728/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-04	Registruotas