Nintedanib Accord

Medicinal product

(Invented) name

Nintedanib Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2024-04-19

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	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
113427	99545	1099545	lizdinė plokštelė	N30		Receptinis	EU/1/24/1803/007	Netiekiama	-	-	No	-	-
113428	99546	1099546	lizdinė plokštelė	N60		Receptinis	EU/1/24/1803/008	Netiekiama	-	-	No	-	-
113429	99547	1099547	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/24/1803/009	Netiekiama	-	-	No	-	-
113430	99548	1099548	dalomoji lizdinė plokštelė	N60×1		Receptinis	EU/1/24/1803/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-19	Registruotas