Foclivia

Medicinal product

(Invented) name

Foclivia

Active substance (s)

A/Vietnam/1194/2004 (H5N1)

Strength

7,5 µg HA/0,5 ml

Pharmaceutical form

injekcinė suspensija

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

Seqirus S.r.l., Italija

Date of authorisation

2009-10-19

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 for injection	0.5 ml
A/Vietnam/1194/2004 (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
100833	86944	1086944	flakonas	1 dozė (0,5 ml) N10		Receptinis	EU/1/09/577/003	Netiekiama	-	-	No	-	-
100834	86945	1086945	flakonas	10 dozių (0,5 ml) N10		Receptinis	EU/1/09/577/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-10-19	Registruotas