EU/3/07/441

Table of contents

About

On 20 March 2007, orphan designation (EU/3/07/441) was granted by the European Commission to Phoqus Pharmaceuticals Ltd, United Kingdom, for hydrocortisone (modified release tablet) for the treatment of adrenal insufficiency.

The sponsorship was transferred to Diurnal Limited, United Kingdom, in February 2009 and subsequently to Diurnal Europe B.V., Netherlands, in February 2019.

Following a corrigendum procedure, the active ingredient was renamed from 'Hydrocortisone
(modified release tablet') to 'Hydrocortisone' in July 2020. 

Key facts

Active substance
hydrocortisone
Disease / condition
Treatment of adrenal insufficiency
Date of first decision
20/03/2007
Outcome
Positive
EU designation number
EU/3/07/441

Sponsor's contact details

Diurnal Europe B.V.
Van Heuven Goedhartlaan 935 A
Amstelveen 
Noord-Holland 
1181 LD 
Netherlands
Tel. +31 20 5646 168
E-mail: regulatory@diurnal.eu

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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