Nintedanib TevaPharm

Medicinal product

(Invented) name

Nintedanib TevaPharm

Active substance (s)

Nintedanibas

Strength

150 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX09, nintedanib

Marketing authorisation holder

Teva GmbH, Vokietija

Date of authorisation

2026-06-04

Date of renewal

Documents

6047_6048_Nintedanib TevaPharm.docx

6048_pakuotes lapelis_2026-06-04.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0601/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Nintedanibas	150 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
121136	107244	1107244	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/26/6048/001	Netiekiama	-	-	No	-	-
121137	107245	1107245	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/26/6048/002	Netiekiama	-	-	No	-	-
121138	107246	1107246	dalomoji lizdinė plokštelė	N120×1		Receptinis	LT/1/26/6048/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-04	Registruotas