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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1396234
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Name of medicinal product:
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ARANESP
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Active substances:
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ATC code:
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B03XA02
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Dosage form:
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solution for injection in pre-filled pen
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Route of administration:
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subcutaneous use; intravenous use
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Strengh:
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15mcg 0.375ml
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Amount in package:
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0.375ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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|
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Amgen Europe B.V.
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Marketing authorization number:
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EU/1/01/185
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Marketing authorization issued on:
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May 23, 2006
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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