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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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1207471
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Name of medicinal product:
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ARANESP
|
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Active substances:
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|
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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 syringe
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Route of administration:
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intravenous use; subcutaneous use
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|
Strengh:
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80mcg 0.4ml
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Amount in package:
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0.4ml 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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|
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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
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
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EST
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|
Labelling:
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|
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Last imported to Estonia:
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17 November 2023
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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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08 June 2001
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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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Percent
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Valid from
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Valid until
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Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
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Age
|
Other
|
|
50
|
24/10/2023
|
|
Yes
|
|
|
No
|
|
|
|
100
|
24/10/2023
|
|
Yes
|
D46-D46; D47.1-D47.1
|
Hematoloog
|
No
|
|
|
|
100
|
24/10/2023
|
|
Yes
|
D63-D63; T86-T86
|
Nefroloog, Pediaater, Uroloog
|
No
|
|
kroonilisest neerupuudulikkusest tingitud aneemia korral
|
|
100
|
24/10/2023
|
|
Yes
|
D63-D63; T86-T86
|
Nefroloog, Uroloog, Pediaater
|
No
|
until 4 years
|
kroonilisest neerupuudulikkusest tingitud aneemia korral
|
|
100
|
24/10/2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
100
|
24/10/2023
|
|
Yes
|
D46-D46; D47.1-D47.1
|
Hematoloog
|
No
|
until 4 years
|
|
|
Reference price:
|
156.00 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