Engerix-B

Medicinal product

(Invented) name

Engerix-B

Active substance (s)

Hepatito B paviršinis antigenas

Strength

10 µg/0,5 ml

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07BC01, Hepatitis B, purified antigen

Marketing authorisation holder

GlaxoSmithKline Biologicals s.a., Belgija

Date of authorisation

1996-03-29

Date of renewal

2010-09-08

Documents

2154 Pakuotės lapelis 10mcg, 20mcg 2023 06 05.docx

2154 Engerix_B 10mcg RPP 2023 06 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Dozėje (0,5 ml) yra	0.5 ml
Hepatito B paviršinis antigenas	10 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
4525	9883	1009883	flakonas	0,5 ml N1		Receptinis	LT/1/96/2154/001	Netiekiama	-	-	No	-	-
4526	9884	1009884	flakonas	0,5 ml N25		Receptinis	LT/1/96/2154/002	Netiekiama	-	-	No	-	-
4527	9885	1009885	flakonas	0,5 ml N100		Receptinis	LT/1/96/2154/003	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-09-08	Perregistruotas
1996-03-29	Registruotas