Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1488337
Name of medicinal product: ADVAGRAF
Active substances:
Tacrolimus
Estonian, English, Latin
ATC code: L04AD02
Dosage form: prolonged-release capsule, hard
Route of administration: oral use
Strengh: 3mg
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: May 22, 2024
Marketing authorization holder: Astellas Pharma Europe B.V. 
Marketing authorization number: EU/1/07/387 
Marketing authorization issued on: April 27, 2009 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     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  05.04.2024     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: 111,00 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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