Tysabri

Medicinal product

(Invented) name

Tysabri

Active substance (s)

Natalizumabas

Strength

300 mg

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)

L04AG03, Natalizumab

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

Date of authorisation

2006-06-27

Date of renewal

Documents

Tysabri kontroliniu klausimu pries injekcija sarasas.pdf

Tysabri gydymo pradejimo ir tesimo forma.pdf

Tysabri informacinis priedas sveikatos prieziuros specialistams.pdf

Tysabri paciento kortele.pdf

Tysabri gydymo nutraukimo forma.pdf

Tysabri 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	15 ml
Natalizumabas	300 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
28973	31485	1031485	flakonas	15 ml N1		Receptinis	EU/1/06/346/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-06-27	Registruotas