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MITACLAU
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
3035900
Name of medicinal product:
MITACLAU
Active substances:
Desmopressin
Estonian
,
English
,
Latin
ATC code:
H01BA02
Dosage form:
sublingual tablet
Route of administration:
sublingual use
Strengh:
120mcg
Amount in package:
20TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
üksikannuseline blister
Indication:
- Treatment of central diabetes insipidus. - Treatment of primary nocturnal enuresis in children from 5 years of age with a normal ability to concentrate urine. - Symptomatic treatment of nocturia in adults aged below 65, associated with nocturnal polyuria, i.e. nocturnal urine production exceeding functional bladder capacity.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated September 11, 2023)
Package information leaflet (PIL):
EST
(last updated September 11, 2023)
Labelling:
(last updated September 13, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Norameda UAB
Marketing authorization number:
1126823
Marketing authorization issued on:
September 11, 2023
Marketing authorization expires on:
September 11, 2028
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: September 13, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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