IDELVION

Medicinal product

(Invented) name

IDELVION

Active substance (s)

Jungtinis baltymas (rDNR), sujungiantis IX koaguliacijos faktorių su albuminu (rIX-FP)

Strength

3500 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B02BD04, Coagulation factor IX

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2016-05-11

Date of renewal

Documents

Stage

Registruotas

Controlled?

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.
Jungtinis baltymas (rDNR), sujungiantis IX koaguliacijos faktorių su albuminu (rIX-FP)	3500 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
104947	91048	1091048	flakonas	N1 (milteliai, tirpiklio flakonas (5 ml), perpylimo įrenginys su filtru, švirkštas (10 ml), venos punkcijos rinkinys, 2 tamponai ir pleistras)		Receptinis	EU/1/16/1095/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-11	Registruotas