Hepetra

Medicinal product

(Invented) name

Hepetra

Active substance (s)

Žmogaus hepatito B imunoglobulinas

Strength

50 TV/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BB04, Hepatitis B immunoglobulin

Marketing authorisation holder

Biotest Pharma GmbH, Vokietija

Date of authorisation

2022-06-09

Date of renewal

2023-04-06

Documents

4957 Hepetra RPP 2025 08 29.docx

4957 Pakuotės lapelis 2025 08 29.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0214/001/E/004

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Žmogaus hepatito B imunoglobulinas	50 TV

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
108769	94875	1094875	flakonas	2 ml N1		Receptinis	LT/1/22/4957/001	Netiekiama	2025-08-21	2025-12-30	No	-	-	Download
108770	94876	1094876	flakonas	10 ml N1		Receptinis	LT/1/22/4957/002	Netiekiama	-	-	No	-	-
108771	94877	1094877	flakonas	40 ml N1		Receptinis	LT/1/22/4957/003	Netiekiama	-	-	No	-	-
108772	94878	1094878	flakonas	100 ml N1		Receptinis	LT/1/22/4957/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-04-06	Perregistruotas
2022-06-09	Registruotas