Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 3035887
Name of medicinal product: MITACLAU
Active substances:
Estonian, English, Latin
ATC code: H01BA02
Dosage form: sublingual tablet
Route of administration: sublingual use
Strengh: 120mcg
Amount in package: 10TK
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 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 
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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