ALPROLIX

Medicinal product

(Invented) name

ALPROLIX

Active substance (s)

Žmogaus IX (rDNR) koaguliacijos faktorius

Strength

500 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

Swedish Orphan Biovitrum AB (publ), Švedija

Date of authorisation

2016-05-12

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	500 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
65854	80365	1080365	flakonas	N1 (milteliai, 5 ml tirpiklio užpildytame švirkšte, stūmoklio kotas, flakono adapteris, infuzinis rinkinys, 2 alkoholiu suvilgyti tamponai, 2 pleistrai ir marlės tamponas)		Receptinis	EU/1/16/1098/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-12	Registruotas