Adjupanrix

Medicinal product

(Invented) name

Adjupanrix

Active substance (s)

A/VietNam/1194/2004 (H5N1) panašios padermės, panaudojus (NIBRG-14)

Strength

3,75 µg/0,5 ml

Pharmaceutical form

suspensija ir emulsija injekcinei emulsijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BB02, influenza, inactivated, split virus or surface antigen

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2009-11-05

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension and emulsion for emulsion for injection	0.5 ml
A/VietNam/1194/2004 (H5N1) panašios padermės, panaudojus (NIBRG-14)	3,75 µg

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
37743	51384	1051384	flakonas	2,5 ml N50 (suspensija) + 2,5 ml N2x25 (emulsija)		Receptinis	EU/1/09/578/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-05	Registruotas