Nintedanib STADA

Medicinal product

(Invented) name

Nintedanib STADA

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2024-02-28

Date of renewal

Documents

5362_5363 Nintedanib STADA PCS PL 2025 05 26.docx

5362 Pakuotės lapelis 2025 05 26.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0545/001/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
113001	99119	1099119	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/24/5362/001	Netiekiama	-	-	No	-	-
113002	99120	1099120	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/24/5362/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-28	Registruotas