HBVAXPRO

Medicinal product

(Invented) name

HBVAXPRO

Active substance (s)

Hepatito B viruso paviršinis (rDNR) antigenas (HbsAg)

Strength

10 µg

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

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2001-04-27

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

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 paviršinis (rDNR) antigenas (HbsAg)	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
108403	94507	1094507	flakonas	1 ml N1		Receptinis	EU/1/01/183/007	Netiekiama	-	-	No	-	-
108404	94508	1094508	flakonas	1 ml N10		Receptinis	EU/1/01/183/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-04-27	Registruotas