Imatinib medac

Medicinal product

(Invented) name

Imatinib medac

Active substance (s)

Imatinibas

Strength

400 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01XE01, Imatinib

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2013-09-25

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsules	1 vnt.
Imatinibas	400 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
57462	71578	1071578	lizdinė plokštelė	N30		Receptinis	EU/1/13/876/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-02-14	Išregistruotas
2013-09-25	Registruotas