Haemate

Medicinal product

(Invented) name

Haemate

Active substance (s)

Žmogaus VIII koaguliacijos faktorius /Žmogaus Willebrando faktorius

Strength

1000 TV/2400 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam ar infuziniam 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

CSL Behring GmbH, Vokietija

Date of authorisation

2022-04-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

FI/H/1113/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Žmogaus VIII koaguliacijos faktorius	1000 TV
Žmogaus Willebrando faktorius	2400 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
108493	94597	1094597	flakonas	milteliai, tirpiklio flakonas (15 ml), tirpalo perpylimo prietaisas su filtru 20/20, suleidimo rinkinys (vienkartinis švirkštas (20 ml), rinkinys venos punkcijai, 2 alkoholiu suvilgyti tamponai, pleistras), N1		Receptinis	LT/1/22/4942/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-11	Registruotas