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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1294635
|
Name of medicinal product:
|
ADVAGRAF
|
Active substances:
|
|
ATC code:
|
L04AD02
|
Dosage form:
|
prolonged-release capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
0,5mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products
in adult patients.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
12 February 2014
|
Marketing authorization holder:
|
Astellas Pharma Europe B.V.
|
Marketing authorization number:
|
EU/1/07/387
|
Marketing authorization issued on:
|
23 April 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
10 March 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription