DARZALEX

Medicinal product

(Invented) name

DARZALEX

Active substance (s)

Daratumumabas

Strength

1800 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FC01, daratumumab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2016-05-20

Date of renewal

Documents

Mokomoji medziaga sveikatos prieziuros specialistams 2.pdf

D-VMP skyrimo tvarkarastis.pdf

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

Gydymo planas.pdf

Paciento kortele.pdf

Vadovas sveikatos prieziuros specialistams.pdf

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

Solution for injection	15 ml
Daratumumabas	1800 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
104429	90531	1090531	flakonas	15 ml N1		Receptinis	EU/1/16/1101/004	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-20	Registruotas