Aranesp

Medicinal product

(Invented) name

Aranesp

Active substance (s)

Darbepoetinas alfa

Strength

500 µg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

2002-08-22

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 pre-filled syringe	1 ml
Darbepoetinas alfa	500 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
24901	27533	1027533	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/01/185/031	Netiekiama	-	-	No	-	-
24902	27534	1027534	užpildytas švirkštas	1 ml N4		Receptinis	EU/1/01/185/032	Netiekiama	-	-	No	-	-
24887	27519	1027519	užpildytas švirkštas	1 ml N1 (ne lizdinėje plokštelėje)		Receptinis	EU/1/01/185/044	Netiekiama	-	-	No	-	-
42975	56744	1056744	užpildytas švirkštas	1 ml N1 (su adatos apsauga)		Receptinis	EU/1/01/185/098	Netiekiama	-	-	No	-	-
42976	56745	1056745	užpildytas švirkštas	1 ml N4 (su adatos apsauga)		Receptinis	EU/1/01/185/099	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-08-22	Registruotas