Nintedanib Viatris

Medicinal product

(Invented) name

Nintedanib Viatris

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

Viatris Limited, Airija

Date of authorisation

2025-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

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
118419	104525	1104525	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/25/1959/001	Netiekiama	-	-	No	-	-
118420	104526	1104526	dalomoji lizdinė plokštelė	N60×1		Receptinis	EU/1/25/1959/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-22	Registruotas