Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic

Medicinal product

(Invented) name

Active substance (s)

Gripo viruso paviršiniai antigenai, į A/Vietnam/1194/2004 (H5N1) panašios padermės

Strength

7,5 µg/dozėje

Pharmaceutical form

injekcinė suspensija užpildytame švirkšte

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

Novartis Vaccines and Diagnostics S.r.l., Italija

Date of authorisation

2010-11-29

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	1 dozėje
Gripo viruso paviršiniai antigenai, į A/Vietnam/1194/2004 (H5N1) panašios padermės	7,5 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
44187	57978	1057978	užpildytas švirkštas	0.5 ml N1		Receptinis	EU/1/10/657/001	Netiekiama	-	-	No	-	-
44188	57979	1057979	užpildytas švirkštas	0.5 ml N10		Receptinis	EU/1/10/657/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2010-11-29	Registruotas