Alkindi

RSS

hydrocortisone

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Alkindi
Agency product number
EMEA/H/C/004416
Active substance
hydrocortisone
International non-proprietary name (INN) or common name
hydrocortisone
Therapeutic area (MeSH)
Adrenal Insufficiency
Anatomical therapeutic chemical (ATC) code
H02AB09
Publication details
Marketing-authorisation holder
Diurnal Europe B.V.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
09/02/2018

Product information

06/09/2018 Alkindi - EMEA/H/C/004416 - T/0003

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.

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

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