Aranesp

Medicinal product

(Invented) name

Aranesp

Active substance (s)

Darbepoetinas alfa

Strength

15 µg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

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 pen	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
108087	94191	1094191	užpildytas švirkštiklis	0,375 ml N1 (SureClick)		Receptinis	EU/1/01/185/046	Netiekiama	-	-	No	-	-
108088	94192	1094192	užpildytas švirkštiklis	0,375 ml N4 (SureClick)		Receptinis	EU/1/01/185/058	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-06-08	Registruotas