Flexbumin

Medicinal product

(Invented) name

Flexbumin

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

Baxalta Innovations GmbH, Austrija

Date of authorisation

2008-06-02

Date of renewal

2011-11-22

Documents

1154 Pakuotės lapelis 2022 02 10.docx

1154 Flexbumin PCS 2023 10 28.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

AT/H/0683/001/

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 l tirpalo yra	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
21482	24365	1024365	maišelis	50 ml N24		Receptinis	LT/1/08/1154/001	Netiekiama	-	-	No	-	-
30200	32667	1032667	maišelis	100 ml N12		Receptinis	LT/1/08/1154/002	Netiekiama	-	-	No	-	-
54149	68137	1068137	maišelis	50 ml N1		Receptinis	LT/1/08/1154/003	Netiekiama	-	-	No	-	-
54150	68138	1068138	maišelis	100 ml N1		Receptinis	LT/1/08/1154/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-11-22	Perregistruotas
2008-06-02	Registruotas