PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Medicinal product

(Invented) name

Active substance (s)

A/Vietnam/1203/2004 (H5N1)

Strength

7,5 µg HA

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BB01, Influenza, inactivated, whole virus

Marketing authorisation holder

Resilience Biomanufacturing Ireland Limited, Airija

Date of authorisation

2009-10-16

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection. Per 0.5 ml dose	0.5 ml
A/Vietnam/1203/2004 (H5N1)	7,5 µg HA

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
109637	95743	1095743	užpildytas švirkštas	0,5 ml N1 (su adata/be adatos)		Receptinis	EU/1/09/571/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-11	Išregistruotas
2009-10-16	Registruotas