Voncento

Medicinal product

(Invented) name

Voncento

Active substance (s)

Žmogaus VIII koaguliacijos faktorius /Žmogaus Willebrando faktorius

Strength

500 TV FVIII/1200 TV VWF

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

2013-08-12

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection or infusion	1 vnt.
Žmogaus VIII koaguliacijos faktorius	500 TV FVIII
Žmogaus Willebrando faktorius	1200 TV VWF

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
57064	71176	1071176	flakonas	N1 + (flakonas injekcinio vandens (10 ml))		Receptinis	EU/1/13/857/002	Netiekiama	-	-	No	-	-
57065	71177	1071177	flakonas	N1 (+ flakonas injekcinio vandens (5 ml))		Receptinis	EU/1/13/857/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-08-12	Registruotas