Tysabri

Medicinal product

(Invented) name

Tysabri

Active substance (s)

Natalizumabas

Strength

150 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)

L04AG03, Natalizumab

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2006-06-27

Date of renewal

Documents

Tysabri gydymo nutraukimo forma.pdf

Tysabri informacinis priedas sveikatos prieziuros specialistams.pdf

Tysabri mokomoji medziaga sveikatos prieziuros specialistams.pdf

Tysabri kontroliniu klausimu pries injekcija sarasas.pdf

Tysabri gydymo pradejimo ir tesimo forma.pdf

Tysabri paciento 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

Užpildytame švirkšte (1 ml tirpalo) yra	1 ml
Natalizumabas	150 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
106251	92352	1092352	užpildytas švirkštas	1 ml N2		Receptinis	EU/1/06/346/002	Tiekiama	-	-	No	-	-
119631	105737	1105737	užpildytas švirkštas	1 ml N6 (3×2)		Receptinis	EU/1/06/346/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-06-27	Registruotas