HEPLISAV B

Medicinal product

(Invented) name

HEPLISAV B

Active substance (s)

Hepatito B viruso paviršinis (rDNR) antigenas (HbsAg)

Strength

20 µg

Pharmaceutical form

injekcinis tirpalas 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

Dynavax GmbH, Vokietija

Date of authorisation

2021-02-18

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

Solution for injection in pre-filled syringe	0.5 ml
Hepatito B viruso paviršinis (rDNR) antigenas (HbsAg)	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
105961	92062	1092062	užpildytas švirkštas	0,5 ml N5 (be adatos)		Receptinis	EU/1/20/1503/001	Netiekiama	-	-	No	-	-
111422	97535	1097535	užpildytas švirkštas	0,5 ml N1 (be adatos)		Receptinis	EU/1/20/1503/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-18	Registruotas