IMMUNATE

Medicinal product

(Invented) name

IMMUNATE

Active substance (s)

Žmogaus VIII koaguliacijos faktorius /Žmogaus plazmos Willebrand'o faktorius

Strength

250 TV/190 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B02BD06, Von Willebrand factor and coagulation factor VIII in combination

Marketing authorisation holder

Baxalta Innovations GmbH, Austrija

Date of authorisation

2006-09-22

Date of renewal

2013-02-08

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

AT/H/0154/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Žmogaus VIII koaguliacijos faktorius	250 TV
Žmogaus plazmos Willebrand'o faktorius	190 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
16149	4580	1004580	flakonas	milteliai, flakonas tirpiklio (5 ml), perkėlimo/filtravimo įtaisas, švirkštas (5 ml), vienkartinė adata, infuzijos rinkinys su sparneliais N1		Receptinis	LT/1/05/0493/001	Netiekiama	-	-	No	-	-

Stadijos