PreHevbri

Medicinal product

(Invented) name

PreHevbri

Active substance (s)

Hepatito B viruso paviršiniai antigenai (S, anti-S1 ir anti-S2)

Strength

10 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

VBI Vaccines B.V., Nyderlandai

Date of authorisation

2022-04-25

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	1 ml
Hepatito B viruso paviršiniai antigenai (S, anti-S1 ir anti-S2)	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
108553	94657	1094657	flakonas	1 ml N10		Receptinis	EU/1/22/1641/001	Netiekiama	-	-	No	-	-
112697	98817	1098817	flakonas	1 ml N1		Receptinis	EU/1/22/1641/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-11-25	Išregistruotas
2022-04-25	Registruotas