Refixia

Medicinal product

(Invented) name

Refixia

Active substance (s)

Žmogaus IX (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)

B02BD04, Coagulation factor IX

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2017-06-02

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 IX (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
110003	96113	1096113	flakonas	milteliai, tirpiklio užpildytas švirkštas (4 ml), stūmoklio strypelis ir flakono adapteris N1		Receptinis	EU/1/17/1193/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-02	Registruotas