Imatinib Grindeks

Medicinal product

(Invented) name

Imatinib Grindeks

Active substance (s)

Imatinibas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EA01, imatinib

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2013-10-31

Date of renewal

2022-05-25

Documents

3421 Pakuotės lapelis 2024 11 04, VRA.docx

3421 Imatinib Grindeks PL 2024 11 04, VRA.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1295/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje 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
52939	66878	1066878	lizdinė plokštelė	N60		Receptinis	LT/1/13/3421/001	Netiekiama	-	-	No	-	-
57767	71887	1071887	lizdinė plokštelė	N120		Receptinis	LT/1/13/3421/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-25	Perregistruotas
2013-10-31	Registruotas