Ofev

Medicinal product

(Invented) name

Ofev

Active substance (s)

Nintedanibas

Strength

25 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

Kapsulėje yra:	1 vnt.
Nintedanibas	25 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
118946	105052	1105052	lizdinė plokštelė	N60		Receptinis	EU/1/14/979/009	Netiekiama	-	-	No	-	-
118964	105070	1105070	buteliukas	N60		Receptinis	EU/1/14/979/010	Netiekiama	-	-	No	-	-
118965	105071	1105071	buteliukas	N120		Receptinis	EU/1/14/979/011	Netiekiama	-	-	No	-	-
118967	105073	1105073	buteliukas	N180		Receptinis	EU/1/14/979/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-15	Registruotas