RoActemra

Medicinal product

(Invented) name

RoActemra

Active substance (s)

Tocilizumabas

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)

L04AC07, Tocilizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2009-01-16

Date of renewal

Documents

0492 Roactemra_lt.pdf

RoActemra mokomoji medziaga pacientams.pdf

RoActemra paciento budrumo kortele.pdf

RoActemra mokomoji medziaga sveikatos prieziuros specialistams.pdf

RoActemra dozavimo atmintine.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
Tocilizumabas	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
33636	35997	1035997	flakonas	4 ml, N1		Receptinis	EU/1/08/492/001	Netiekiama	-	-	No	-	-
33637	35998	1035998	flakonas	4 ml, N4		Receptinis	EU/1/08/492/002	Tiekiama	-	-	No	-	-
33638	35999	1035999	flakonas	10 ml, N1		Receptinis	EU/1/08/492/003	Netiekiama	-	-	No	-	-
33639	36000	1036000	flakonas	10 ml, N4		Receptinis	EU/1/08/492/004	Netiekiama	-	-	No	-	-
33640	36001	1036001	flakonas	20 ml, N1		Receptinis	EU/1/08/492/005	Netiekiama	-	-	No	-	-
33641	36002	1036002	flakonas	20 ml, N4		Receptinis	EU/1/08/492/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-01-16	Registruotas