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Product class:
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Medicinal product with marketing authorization
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|
Medicinal product class:
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Human medicine
|
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Name of medicinal product:
|
ADVAGRAF
|
|
Active substances:
|
|
|
ATC code:
|
L04AD02
|
|
Dosage form:
|
prolonged-release capsule, hard
|
|
Strength:
|
1mg
|
|
Legal status for supply*:
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Subject to medicinal prescription
|
|
Summary of product characteristics (SPC):
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|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
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
|
|
Marketing authorization holder:
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Astellas Pharma Europe B.V.
|
|
Marketing authorization number:
|
EU/1/07/387
|
|
Marketing authorization issued on:
|
April 23, 2007
|
|
Marketing authorization expires on:
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Unlimited
|
|
Marketing authorization procedure type:
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Centralised
|
|
Assessment report:
|
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
|
1294679
|
ADVAGRAF
|
prolonged-release capsule, hard
|
1mg 30TK
|
Prescription
|
|
|
|
|
|
|
1294680
|
ADVAGRAF
|
prolonged-release capsule, hard
|
1mg 50TK
|
Prescription
|
100%
|
37,00
|
01.02.2023
|
|
|
|
1294691
|
ADVAGRAF
|
prolonged-release capsule, hard
|
1mg 60TK
|
Prescription
|
|
|
|
|
|
|
1294703
|
ADVAGRAF
|
prolonged-release capsule, hard
|
1mg 100TK
|
Prescription
|
|
|
17.09.2015
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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