DARZALEX

Medicinal product

(Invented) name

DARZALEX

Active substance (s)

Daratumumabas

Strength

20 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

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

Paciento kortele.pdf

Gydymo planas.pdf

D-VMP skyrimo tvarkarastis.pdf

Vadovas sveikatos prieziuros specialistams.pdf

Mokomoji medziaga sveikatos prieziuros specialistams 2.pdf

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Daratumumabas	20 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
65868	80380	1080380	flakonas	5 ml N1		Receptinis	EU/1/16/1101/001	Tiekiama	-	2025-07-01	No	-	-
65869	80381	1080381	flakonas	20 ml N1		Receptinis	EU/1/16/1101/002	Tiekiama	-	2025-07-01	No	-	-
104430	90532	1090532	flakonas	N11 (6 x 5 ml + 5 x 20 ml)		Receptinis	EU/1/16/1101/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-20	Registruotas