Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ALKINDI
Active substances:
Hydrocortisone
Estonian, English, Latin
ATC code: H02AB09
Dosage form: granules in single-dose container
Strength: 2mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).
Safety features: Yes
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: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1764547  ALKINDI  granules in single-dose container  2mg 50TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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