Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ALKINDI
|
Active substances:
|
|
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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