Product class:
|
Authorized package
|
Medicinal product class:
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For human use
|
Package code:
|
1201532
|
Name of medicinal product:
|
AMMONAPS
|
Active substances:
|
|
ATC code:
|
A16AX03
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
500mg
|
Amount in package:
|
500TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders,
involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or
argininosuccinate synthetase.
It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies,
presenting within the first 28 days of life). It is also indicated in patients with late-onset disease
(partial enzyme deficiencies, presenting after the first month of life) who have a history of
hyperammonaemic encephalopathy.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
Immedica Pharma AB
|
Marketing authorization number:
|
EU/1/99/120
|
Marketing authorization issued on:
|
December 8, 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
July 1, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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