Nintedanib Sandoz

Medicinal product

(Invented) name

Nintedanib Sandoz

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

Sandoz d.d., Slovėnija

Date of authorisation

2025-01-20

Date of renewal

Documents

5672_5673 Nintedanib Sandoz PCS PL 2025 06 05, PL tik 150mg.docx

5673 Pakuotės lapelis 150mg 2025 06 05.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5725/002/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
116331	102433	1102433	dalomoji lizdinė plokštelė	N30×1		Receptinis	LT/1/25/5673/001	Netiekiama	-	-	No	-	-
116332	102434	1102434	dalomoji lizdinė plokštelė	N60×1		Receptinis	LT/1/25/5673/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-01-20	Registruotas