Xospata

Medicinal product

(Invented) name

Xospata

Active substance (s)

Gilteritinibas

Strength

40 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)

L01EX13, gilteritinib

Marketing authorisation holder

Astellas Pharma Europe B.V., Nyderlandai

Date of authorisation

2019-10-24

Date of renewal

Documents

Xospata paciento kortele.pdf

Xospata mokomoji medziaga sveikatos prieziuros specialistams.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

Tabletėje yra	1 vnt.
Gilteritinibas	40 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
102789	88890	1088890	lizdinė plokštelė	N84		Receptinis	EU/1/19/1399/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-10-24	Registruotas