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](/en/medicines/human/orphan-designations/eu-3-06-372) 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 Plenadren was withdrawn from the Community register of orphan medicinal products in November 2021 at the end of the 10\-year period of market exclusivity.
Therapeutic Indication
Treatment of adrenal insufficiency in adults.
Therapeutic Area (MeSH)
ATC Code
H02AB09
ATC Item
N/A
Pharmacotherapeutic Group
Corticosteroids for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| hydrocortisone | N/A | hydrocortisone |
EMA Name
Plenadren
Medicine Name
Plenadren
Aliases
N/ANo risk management plan link.
