Product class:
|
Authorized package
|
Medicinal product class:
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For human use
|
Package code:
|
1294668
|
Name of medicinal product:
|
ADVAGRAF
|
Active substances:
|
|
ATC code:
|
L04AD02
|
Dosage form:
|
prolonged-release capsule, hard
|
Route of administration:
|
oral use
|
Strengh:
|
5mg
|
Amount in package:
|
50TK
|
Legal status for supply*:
|
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:
|
March 21, 2024
|
Marketing authorization holder:
|
Astellas Pharma Europe B.V.
|
Marketing authorization number:
|
EU/1/07/387
|
Marketing authorization issued on:
|
April 23, 2007
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
Z94-Z94; T86-T86
|
|
No
|
until 4 years
|
patsientidele, kellel esineb kõrge immunoloogiline risk (PRA >20%), korduvsiirdamise puhul, maksa- või kopsusiirdamise pihul, steroidresistentse ägeda äratõukereaktsiooni ravi järgselt ning müokardiinfarkti või müokardi revaskulariseeriva protseduuri järgselt
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
Z94-Z94; T86-T86
|
|
No
|
|
patsientidele, kellel esineb kõrge immunoloogiline risk (PRA >20%), korduvsiirdamise puhul, maksa- või kopsusiirdamise pihul, steroidresistentse ägeda äratõukereaktsiooni ravi järgselt ning müokardiinfarkti või müokardi revaskulariseeriva protseduuri järgselt
|
Reference price:
|
185,00 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,74 EUR
|
Entry/Changing date:
March 10, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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