Aranesp

Medicinal product

(Invented) name

Aranesp

Active substance (s)

Darbepoetinas alfa

Strength

25 µg

Pharmaceutical form

injekcinis tirpalas flakone

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B03XA02, Darbepoetin alfa

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2011-02-28

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

Solution for injection in vial	1 ml
Darbepoetinas alfa	25 µg

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
45748	59550	1059550	flakonas	1 ml N1		Receptinis	EU/1/01/185/100	Netiekiama	-	-	No	-	-
45749	59551	1059551	flakonas	1 ml N4		Receptinis	EU/1/01/185/101	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-02-28	Registruotas