Imatinib Inteli

Medicinal product

(Invented) name

Imatinib Inteli

Active substance (s)

Imatinibas

Strength

400 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)

L01EA01, imatinib

Marketing authorisation holder

UAB Inteli Generics Nord, Lietuva

Date of authorisation

2016-11-22

Date of renewal

2022-08-01

Documents

4005 Pakuotės lapelis 2024 11 13.docx

4005 Imatinib Inteli PCS PL 2024 11 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3510/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
62565	76976	1076976	lizdinė plokštelė	N10		Receptinis	LT/1/16/4005/005	Tiekiama	-	-	No	-	-
62566	76977	1076977	lizdinė plokštelė	N30		Receptinis	LT/1/16/4005/006	Tiekiama	-	-	No	-	-
67171	81715	1081715	lizdinė plokštelė	N90		Receptinis	LT/1/16/4005/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-01	Perregistruotas
2016-11-22	Registruotas