ADYNOVI

Medicinal product

(Invented) name

ADYNOVI

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

3000 TV/5 ml

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

Baxalta Innovations GmbH, Austrija

Date of authorisation

2018-01-08

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	5 ml
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
107832	93937	1093937	flakonas	milteliai, tirpiklio flakonas (5 ml), „BAXJECT II Hi-Flow“ įtaisas N1		Receptinis	EU/1/17/1247/015	Netiekiama	-	-	No	-	-
107833	93938	1093938	flakonas	milteliai, tirpiklio flakonas (5 ml), BAXJECT III sistemoje N1		Receptinis	EU/1/17/1247/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas