Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1397011
Name of medicinal product: ARANESP
Active substances:
Darbepoetin alfa
Estonian, English, Latin
ATC code: B03XA02
Dosage form: solution for injection in pre-filled pen
Route of administration: subcutaneous use; intravenous use
Strengh: 500mcg 1ml
Amount in package: 1ml 4TK
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: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 18, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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