Ofev

Medicinal product

(Invented) name

Ofev

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

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

2015-01-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Soft capsule	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
61135	75449	1075449	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/14/979/001	Netiekiama	-	-	No	-	-
61136	75450	1075450	dalomoji lizdinė plokštelė	N60x1		Receptinis	EU/1/14/979/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas