ADVATE

Medicinal product

(Invented) name

ADVATE

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

3000 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	3000 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
30379	32841	1032841	flakonas	milteliai, 5 ml tirpiklio ir ir prietaisas tirpalo paruošimui N1		Receptinis	EU/1/03/271/006	Netiekiama	-	-	No	-	-
60694	74983	1074983	flakonas	milteliai, 5 ml tirpiklio, iš anksto įdėto į tirpinimo prietaisą N1		Receptinis	EU/1/03/271/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-05-22	Registruotas