Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ADENURIC
|
Active substances:
|
|
ATC code:
|
M04AA03
|
Dosage form:
|
film-coated tablet
|
Strength:
|
120mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
ADENURIC is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
ADENURIC is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
ADENURIC is indicated in adults.
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Menarini International Operations Luxembourg S.A.
|
Marketing authorization number:
|
EU/1/08/447
|
Marketing authorization issued on:
|
April 21, 2008
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1349300
|
ADENURIC
|
film-coated tablet
|
120mg 28TK
|
Prescription
|
100% 90% 50% 75%
|
11,76
|
09.11.2023
|
|
|
1349311
|
ADENURIC
|
film-coated tablet
|
120mg 84TK
|
Prescription
|
|
|
|
|
|
1493007
|
ADENURIC
|
film-coated tablet
|
120mg 14TK
|
Prescription
|
|
|
|
|
|
1493018
|
ADENURIC
|
film-coated tablet
|
120mg 42TK
|
Prescription
|
|
|
|
|
|
1493029
|
ADENURIC
|
film-coated tablet
|
120mg 56TK
|
Prescription
|
|
|
|
|
|
1493030
|
ADENURIC
|
film-coated tablet
|
120mg 98TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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