Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1685505
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Name of medicinal product:
|
ALLOPURINOL SANDOZ
|
Active substances:
|
|
ATC code:
|
M04AA01
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
100mg
|
Amount in package:
|
50TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Adults
All forms of hyperuricaemia not controllable by diet, including secondary hyperuricaemia of differing origin and clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy and for the dissolution and prevention of uric acid stones.
The management of recurrent mixed calcium oxalate stones in concurrent hyperuricaemia, when fluid, dietary and similar measures have failed.
Children and adolescents
Secondary hyperuricaemia of differing origin
Uric acid nephropathy during treatment of leukaemia
Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial or total hypoxanthin-guanin phosphoribosyl transferase deficiency) and adenine phosophoribosyl transferase deficiency.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated January 28, 2022)
|
Package information leaflet (PIL):
|
EST (last updated January 28, 2022)
|
Labelling:
|
(last updated September 13, 2016)
|
Last imported to Estonia:
|
March 22, 2024
|
Marketing authorization holder:
|
Sandoz Pharmaceuticals d.d.
|
Marketing authorization number:
|
914016
|
Marketing authorization issued on:
|
September 13, 2016
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
from 63 years
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
until 4 years
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
|
|
90
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
4 years - 17 years
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
until 4 years
|
|
75
|
01.01.2024
|
01.04.2024
|
Yes
|
M10-M10; N20-N23
|
|
No
|
|
|
50
|
01.01.2024
|
01.04.2024
|
Yes
|
|
|
No
|
|
|
Reference price:
|
2,00 EUR
|
Under reference price:
|
No
|
Reference price of daily dose:
|
0,16 EUR
|
Entry/Changing date:
February 23, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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