ADYNOVI

Medicinal product

(Invented) name

ADYNOVI

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

1000 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	1000 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
98712	84816	1084816	flakonas	milteliai, 5 ml tirpiklio ir BAXJECT II HI-Flow įtaisas N1		Receptinis	EU/1/17/1247/011	Netiekiama	-	-	No	-	-
98713	84817	1084817	flakonas	milteliai, 5 ml tirpiklio ir BAXJECT III sistema N1		Receptinis	EU/1/17/1247/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas