Fendrix

Medicinal product

(Invented) name

Fendrix

Active substance (s)

Hepatito B paviršinis antigenas/AS04C adjuvantas, kurį sudaro: 3-O-desacil-4’-monofosforillipidas A (MFL)

Strength

20 µg/50 µg

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BC01, Hepatitis B, purified antigen

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

2005-02-02

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	0.5 ml
Hepatito B paviršinis antigenas	20 µg
AS04C adjuvantas, kurį sudaro: 3-O-desacil-4’-monofosforillipidas A (MFL)	50 µg

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
25808	28400	1028400	užpildytas švirkštas	0,5 ml N1 + adata	Receptinis	EU/1/04/299/001	Netiekiama	-	-	No	-	-
25809	28401	1028401	užpildytas švirkštas	0,5 ml N1	Receptinis	EU/1/04/299/002	Netiekiama	-	-	No	-	-
25810	28402	1028402	užpildytas švirkštas	0,5 ml N10	Receptinis	EU/1/04/299/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-02-02	Registruotas