Imbruvica

Medicinal product

(Invented) name

Imbruvica

Active substance (s)

Ibrutinibas

Strength

280 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EL01, ibrutinib

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2014-10-21

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

Film-coated tablet	1 vnt.
Ibrutinibas	280 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
101578	87681	1087681	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/14/945/009	Netiekiama	-	-	No	-	-
101579	87682	1087682	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/14/945/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-10-21	Registruotas