AFSTYLA

Medicinal product

(Invented) name

AFSTYLA

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

1500 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

CSL Behring GmbH, Vokietija

Date of authorisation

2017-01-04

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	1500 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
67451	82003	1082003	flakonas	milteliai, flakonas (5 ml) injekcinio vandens ir įtaiso pakuotė (perpylimo įtaisas su filtru 20/20, vienkartinis švirkštas (10 ml), venos punkcijos rinkinys, 2 alkoholiu suvilgyti tamponai ir 1 nesterilus pleistras) N1 (Ne RFID)		Receptinis	EU/1/16/1158/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Registruotas