|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1349300
|
|
Name of medicinal product:
|
ADENURIC
|
|
Active substances:
|
|
|
ATC code:
|
M04AA03
|
|
Dosage form:
|
film-coated tablet
|
|
Route of administration:
|
oral use
|
|
Strengh:
|
120mg
|
|
Amount in package:
|
28TK
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Class of active substance:
|
|
|
Additional information:
|
|
|
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
|
|
Summary of product characteristics (SPC):
|
|
|
Package information leaflet (PIL):
|
EST
|
|
Labelling:
|
|
|
Last imported to Estonia:
|
09 November 2023
|
|
Marketing authorization holder:
|
Menarini International Operations Luxembourg S.A.
|
|
Marketing authorization number:
|
EU/1/08/447
|
|
Marketing authorization issued on:
|
21 April 2008
|
|
Marketing authorization expires on:
|
Unlimited
|
|
Marketing authorization procedure type:
|
Centralised
|
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
|
75
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
90
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
from 63 years
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
90
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
50
|
24/10/2023
|
|
Yes
|
|
|
No
|
|
|
|
90
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
4 years - 17 years
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
100
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
until 4 years
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
90
|
24/10/2023
|
|
Yes
|
M10-M10
|
|
No
|
|
juhul, kui allopurinool on vastunäidustatud või talumatu (põhjustab ravi katkestama sundivaid või annuse tõstmist takistavaid kõrvaltoimeid)
|
|
100
|
24/10/2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
Reference price:
|
11.76 EUR
|
|
Under reference price:
|
No
|
|
Reference price of daily dose:
|
0.28 EUR
|
Entry/Changing date:
27 April 2015
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription