Imbruvica

Medicinal product

(Invented) name

Imbruvica

Active substance (s)

Ibrutinibas

Strength

420 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	420 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
99985	86093	1086093	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/14/945/005	Tiekiama	-	-	No	-	-
101580	87683	1087683	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/14/945/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-10-21	Registruotas