Nintedanib Zentiva

Medicinal product

(Invented) name

Nintedanib Zentiva

Active substance (s)

Nintedanibas

Strength

100 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

Zentiva k.s., Čekija

Date of authorisation

2024-02-28

Date of renewal

Documents

5364 Pakuotės lapelis 2025 09 12.docx

5364_5365 Nintedanib Zentiva RPP 2025 09 12.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0548/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Nintedanibas	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
113003	99121	1099121	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/24/5364/001	Netiekiama	-	-	No	-	-
113004	99122	1099122	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/24/5364/002	Tiekiama	2026-04-01	-	No	-	-
118740	104845	1104845	dalomoji lizdinė plokštelė	N120x1		Receptinis	LT/1/24/5364/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-28	Registruotas