Product class: Authorized package
Medicinal product class: For human use
Package code: 1207370
Name of medicinal product: ARANESP
Active substances:
Darbepoetin alfa
Estonian, English, Latin
ATC code: B03XA02
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use; intravenous use
Strengh: 40mcg 0.4ml
Amount in package: 0.4ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients (see section 4.2). Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 20 January 2023
Marketing authorization holder: Amgen Europe B.V. 
Marketing authorization number: EU/1/01/185 
Marketing authorization issued on: 08 June 2001 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  12/01/2023     Yes      No      
100  12/01/2023     Yes      No  until 4 years   
100  12/01/2023     Yes  D46-D46; D47.1-D47.1  Hematoloog  No  until 4 years   
100  12/01/2023     Yes  D63-D63; T86-T86  Nefroloog, Uroloog, Pediaater  No     kroonilisest neerupuudulikkusest tingitud aneemia korral 
100  12/01/2023     Yes  D63-D63; T86-T86  Pediaater, Uroloog, Nefroloog  No  until 4 years  kroonilisest neerupuudulikkusest tingitud aneemia korral 
100  12/01/2023     Yes  D46-D46; D47.1-D47.1  Hematoloog  No      
Reference price: 78.00 EUR 
Under reference price: Yes 
Reference price of daily dose: 1.95 EUR 
Entry/Changing date: 18 February 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription