Alkindi

hydrocortisone

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This is a summary of the European public assessment report (EPAR) for Alkindi. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Alkindi.

For practical information about using Alkindi, patients should read the package leaflet or contact their doctor or pharmacist.

What is Alkindi and what is it used for?

Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.

Cortisol is needed to control many body processes (including inflammation and the control of sugar and mineral levels) and is sometimes referred to as the ‘stress hormone’ because it helps the body respond to stress. A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.

Alkindi is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.

Alkindi contains the active substance hydrocortisone.

How is Alkindi used?

Alkindi is available as capsules containing granules. The capsules are opened and the granules are placed in the child’s mouth. The child should then be given water or milk to swallow the granules. The granules can also be sprinkled on a spoonful of soft food and given to the child immediately.

The dose is chosen to be lowest possible that controls the child’s symptoms. For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Alkindi work?

The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body’s adrenal gland. Hydrocortisone replaces the natural cortisol that is missing in children whose adrenal glands do not produce enough of the hormone, thereby helping to relieve their symptoms.

What benefits of Alkindi have been shown in studies?

Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.

As for every medicine, the company provided studies on the quality of Alkindi. The company also carried out studies to show that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

What are the risks associated with Alkindi?

No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines. These include changes in behaviour, nausea, inflammation in the lining of the stomach and changes in blood potassium levels and excess acid in the blood. For the full list of side effects see the package leaflet.

Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi. It must also not be used in children with difficulty swallowing or in premature babies who haven’t started feeding by mouth.

Why is Alkindi approved?

Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU. Alkindi is also available in a form suitable for children and it is easier to give a precise dose with Alkindi than with other treatments which require crushing tablets and weighing up the right dose.

The European Medicines Agency concluded that the benefits of Alkindi are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Alkindi?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alkindi have been included in the summary of product characteristics and the package leaflet.

Other information about Alkindi

The European Commission granted a marketing authorisation valid throughout the European Union for Alkindi on 9 February 2018.

For more information about treatment with Alkindi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Alkindi : EPAR - Summary for the public BG = bălgarski 2018-03-01  
Alkindi : EPAR - Summary for the public ES = español 2018-03-01  
Alkindi : EPAR - Summary for the public CS = čeština 2018-03-01  
Alkindi : EPAR - Summary for the public DA = dansk 2018-03-01  
Alkindi : EPAR - Summary for the public DE = Deutsch 2018-03-01  
Alkindi : EPAR - Summary for the public ET = eesti keel 2018-03-01  
Alkindi : EPAR - Summary for the public EL = elliniká 2018-03-01  
Alkindi : EPAR - Summary for the public EN = English 2018-03-01  
Alkindi : EPAR - Summary for the public FR = français 2018-03-01  
Alkindi : EPAR - Summary for the public IT = italiano 2018-03-01  
Alkindi : EPAR - Summary for the public LV = latviešu valoda 2018-03-01  
Alkindi : EPAR - Summary for the public LT = lietuvių kalba 2018-03-01  
Alkindi : EPAR - Summary for the public HU = magyar 2018-03-01  
Alkindi : EPAR - Summary for the public MT = Malti 2018-03-01  
Alkindi : EPAR - Summary for the public NL = Nederlands 2018-03-01  
Alkindi : EPAR - Summary for the public PL = polski 2018-03-01  
Alkindi : EPAR - Summary for the public PT = português 2018-03-01  
Alkindi : EPAR - Summary for the public RO = română 2018-03-01  
Alkindi : EPAR - Summary for the public SK = slovenčina 2018-03-01  
Alkindi : EPAR - Summary for the public SL = slovenščina 2018-03-01  
Alkindi : EPAR - Summary for the public FI = suomi 2018-03-01  
Alkindi : EPAR - Summary for the public SV = svenska 2018-03-01  
Alkindi : EPAR - Summary for the public HR = Hrvatski 2018-03-01  
Name Language First published Last updated
Alkindi : EPAR - Risk-management-plan summary (English only) 2018-03-01  

This EPAR was last updated on 01/03/2018 .

Authorisation details

Product details

Product details for Alkindi
NameAlkindi
Agency product numberEMEA/H/C/004416
Active substance

hydrocortisone

International non-proprietary name (INN) or common name

hydrocortisone

Therapeutic area Adrenal Insufficiency
Anatomical therapeutic chemical (ATC) code H02AB09

Publication details

Publication details for Alkindi
Marketing-authorisation holder

Diurnal Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union09/02/2018

Contact address:

Diurnal Limited
Cardiff Medicentre Heath Park 
Cardiff CF14 4UJ 
United Kingdom

Product information

Product information

09/02/2018  Alkindi -EMEA/H/C/004416 --

Name Language First published Last updated
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  
Alkindi : EPAR - Product Information EN = English 2018-03-01  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  
Alkindi : EPAR - All Authorised presentations EN = English 2018-03-01  

Pharmacotherapeutic group

Corticosteroids for systemic use

Therapeutic indication

Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Alkindi : EPAR - Public assessment report EN = English 2018-03-01  
CHMP summary of positive opinion for Alkindi EN = English 2017-12-15