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 užpildytame švirkšte

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

UAB Lex ano, Lietuva

Date of authorisation

2023-01-27

Date of renewal

Documents

1810_1811_Engerix B inj_susp_uzpild_svirkste_PZPL_2023-01-27.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
110299	96410	1096410	užpildytas švirkštas	0,5 ml N1	ASPĮ	Receptinis	LT/L/23/1810/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-01-27	Registruotas