ADVATE

Medicinal product

(Invented) name

ADVATE

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

2000 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

Takeda Manufacturing Austria AG, Austrija

Date of authorisation

2008-05-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

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	1 vnt.
Žmogaus VIII (rDNR) koaguliacijos faktorius	2000 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
30378	32840	1032840	flakonas	milteliai, 5 ml tirpiklio ir ir prietaisas tirpalo paruošimui N1		Receptinis	EU/1/03/271/005	Netiekiama	-	-	No	-	-
60693	74982	1074982	flakonas	milteliai, 5 ml tirpiklio, iš anksto įdėto į tirpinimo prietaisą N1		Receptinis	EU/1/03/271/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-05-22	Registruotas