RoActemra

Medicinal product

(Invented) name

RoActemra

Active substance (s)

Tocilizumabas

Strength

162 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 mokomoji medziaga pacientams.pdf

RoActemra mokomoji medziaga sveikatos prieziuros specialistams.pdf

RoActemra dozavimo atmintine.pdf

RoActemra paciento budrumo kortele.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 in pre-filled pen	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
100135	86244	1086244	užpildytas švirkštiklis	N4 (ACTPen)		Receptinis	EU/1/08/492/009	Netiekiama	-	-	No	-	-
100136	86245	1086245	užpildytas švirkštiklis	N12 (3x4) (ACTPen, grupinė)		Receptinis	EU/1/08/492/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-01-16	Registruotas