|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1396223
|
|
Name of medicinal product:
|
ARANESP
|
|
Active substances:
|
|
|
ATC code:
|
B03XA02
|
|
Dosage form:
|
solution for injection in pre-filled pen
|
|
Route of administration:
|
subcutaneous use; intravenous use
|
|
Strengh:
|
10mcg 0.4ml
|
|
Amount in package:
|
0.4ml 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
You can download Acrobat Reader fromhere