ALBUMIN Baxalta

Medicinal product

(Invented) name

ALBUMIN Baxalta

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

2007-11-12

Date of renewal

2011-04-21

Documents

0642 ALBUMIN Baxalta 200g II PL 2022 02 16.docx

0642 Pakuotės lapelis 200g 2022 02 16.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4922/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tirpalas, turintis:	1000 ml
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
19354	22680	1022680	flakonas	50 ml, N1		Receptinis	LT/1/06/0642/005	Netiekiama	-	-	No	-	-
25007	27633	1027633	flakonas	50 ml, N70		Receptinis	LT/1/06/0642/006	Netiekiama	-	-	No	-	-
25008	27634	1027634	flakonas	100 ml, N1		Receptinis	LT/1/06/0642/007	Tiekiama	-	-	No	-	-
25009	27635	1027635	flakonas	100 ml, N56		Receptinis	LT/1/06/0642/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-04-21	Perregistruotas
2007-11-12	Registruotas