Engerix-B

Medicinal product

(Invented) name

Engerix-B

Active substance (s)

Hepatito B paviršinis antigenas

Strength

20 µg/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 Engerix_B 20mcg PCS PL 2023 06 05.docx

2154 Pakuotės lapelis 10mcg, 20mcg 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 (1 ml) yra	1 ml
Hepatito B paviršinis antigenas	20 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
4523	9881	1009881	flakonas	1 ml N1		Receptinis	LT/1/96/2154/005	Netiekiama	-	-	No	-	-
4524	9882	1009882	flakonas	1 ml N25		Receptinis	LT/1/96/2154/006	Netiekiama	-	-	No	-	-

Stadijos

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