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 product is no longer an orphan medicine. It was originally designated an orphan medicine on 22 May 2006. Plenadren was withdrawn from the Community register of orphan medicinal products in November 2021 at the end of the 10-year period of market exclusivity.

This EPAR was last updated on 06/12/2022

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
Publication details
Marketing-authorisation holder
Takeda Pharmaceuticals International AG Ireland Branch
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
03/11/2011
Contact address

Block 2 Miesian Plaza
50-58 Baggot Street Lower
Dublin 2
Co Dublin
D02 HW68
Ireland

Product information

06/12/2022 Plenadren - EMEA/H/C/002185 - IAIN/0039/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Corticosteroids for systemic use

Therapeutic indication

Treatment of adrenal insufficiency in adults.

Assessment history

How useful was this page?

Add your rating
Average
1 rating
1 rating
2 ratings