Aranesp

Medicinal product

(Invented) name

Aranesp

Active substance (s)

Darbepoetinas alfa

Strength

15 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

2001-06-08

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	0.375 ml
Darbepoetinas alfa	15 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
24808	27450	1027450	užpildytas švirkštas	0,375 ml N1		Receptinis	EU/1/01/185/003	Netiekiama	-	-	No	-	-
24809	27451	1027451	užpildytas švirkštas	0,375 ml N4		Receptinis	EU/1/01/185/004	Netiekiama	-	-	No	-	-
24812	27454	1027454	užpildytas švirkštas	0,375 ml N1 (ne lizdinėje pakuotėje)		Receptinis	EU/1/01/185/034	Netiekiama	-	-	No	-	-
42949	56718	1056718	užpildytas švirkštas	0,375 ml N1 (su adatos apsauga)		Receptinis	EU/1/01/185/076	Netiekiama	-	-	No	-	-
42950	56719	1056719	užpildytas švirkštas	0,375 ml N4 (su adatos apsauga)		Receptinis	EU/1/01/185/077	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-06-08	Registruotas