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 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

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 in pre-filled syringe	0.5 ml
A/Vietnam/1194/2004 (H5N1)	7,5 µg HA

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
37739	51380	1051380	užpildytas švirkštas	0,5 ml su adata N1	Receptinis	EU/1/09/577/001	Netiekiama	-	-	No	-	-
37740	51381	1051381	užpildytas švirkštas	0,5 ml su adata N10	Receptinis	EU/1/09/577/002	Netiekiama	-	-	No	-	-
100831	86942	1086942	užpildytas švirkštas	0,5 ml be adatos N1	Receptinis	EU/1/09/577/005	Netiekiama	-	-	No	-	-
100832	86943	1086943	užpildytas švirkštas	0,5 ml be adatos N10	Receptinis	EU/1/09/577/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-10-19	Registruotas