Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ARANESP
Active substances:
Darbepoetin alfa
Estonian, English, Latin
ATC code: B03XA02
Dosage form: solution for injection in pre-filled pen
Strength: 500mcg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Amgen Europe B.V. 
Marketing authorization number: EU/1/01/185 
Marketing authorization issued on: May 23, 2006 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1397000  ARANESP  solution for injection in pre-filled pen  500mcg 1ml 1ml 1TK  Prescription           
1397011  ARANESP  solution for injection in pre-filled pen  500mcg 1ml 1ml 4TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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