Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1764525
Name of medicinal product: ALKINDI
Active substances:
Hydrocortisone
Estonian, English, Latin
ATC code: H02AB09
Dosage form: granules in single-dose container
Route of administration: oral use
Strengh: 0,5mg
Amount in package: 50TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
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: Diurnal Europe B.V. 
Marketing authorization number: EU/1/17/1260 
Marketing authorization issued on: February 13, 2018 
Marketing authorization expires on: February 13, 2023 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: March 19, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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