Human albumin Biotest

Medicinal product

(Invented) name

Human albumin Biotest

Active substance (s)

Žmogaus albuminas

Strength

200 g/l

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B05AA01, Albumin

Marketing authorisation holder

Biotest Pharma GmbH, Vokietija

Date of authorisation

2021-12-07

Date of renewal

2022-12-08

Documents

4865 Human albumin Biotest PCS PL 2025 03 28.docx

4865 Pakuotės lapelis 2025 03 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

DE/H/0482/002/E/003

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tirpalas, kurį sudaro:	1 l
Žmogaus albuminas	200 g

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
107704	93809	1093809	flakonas	50 ml N1		Receptinis	LT/1/21/4865/001	Netiekiama	-	-	No	-	-	Download
107705	93810	1093810	flakonas	100 ml N1		Receptinis	LT/1/21/4865/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-12-08	Perregistruotas
2021-12-07	Registruotas