Plenadren

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

This EPAR was last updated on 13/06/2018

Authorisation details

Product details
Name
Plenadren
Agency product number
EMEA/H/C/002185
Active substance
hydrocortisone
International non-proprietary name (INN) or common name
hydrocortisone
Therapeutic area (MeSH)
Adrenal Insufficiency
Anatomical therapeutic chemical (ATC) code
H02AB09
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Shire Services BVBA
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
02/11/2011
Contact address
Rue Montoyer 47
B-1000 Brussels
Belgium

Product information

15/05/2018 Plenadren - EMEA/H/C/002185 - IB/0028/G

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

Treatment of adrenal insufficiency in adults.

Assessment history

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