Plenadren
hydrocortisone
Table of contents
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 Plenadren was withdrawn from the Community register of orphan medicinal products in November 2021 at the end of the 10-year period of market exclusivity.
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 |
Product information
06/12/2022 Plenadren - EMEA/H/C/002185 - IAIN/0039/G
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.