TIBALDIX

Medicinal product

(Invented) name

TIBALDIX

Active substance (s)

Imatinibas

Strength

100 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)

L01XE01, Imatinib

Marketing authorisation holder

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2013-02-28

Date of renewal

Documents

3239_1_2 TIBALDIX tab RPP 161110.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2541/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Imatinibas	100 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
49995	63868	1063868	lizdinė plokštelė	N60		Receptinis	LT/1/13/3239/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2013-02-28	Registruotas