RoActemra

Medicinal product

(Invented) name

RoActemra

Active substance (s)

Tocilizumabas

Strength

162 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

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

RoActemra paciento budrumo kortele.pdf

RoActemra dozavimo atmintine.pdf

RoActemra mokomoji medziaga sveikatos prieziuros specialistams.pdf

RoActemra mokomoji medziaga pacientams.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

Solution for injection	0.9 ml
Tocilizumabas	162 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
59693	73927	1073927	užpildytas švirkštas	0,9 ml N4		Receptinis	EU/1/08/492/007	Tiekiama	-	-	No	-	-
61804	76160	1076160	užpildytas švirkštas	0,9 ml N12 (3x4) (sudėtinė)		Receptinis	EU/1/08/492/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-01-16	Registruotas