EU/3/02/124

Table of contents

About

On 18 December 2002, orphan designation (EU/3/02/124) was granted by the European Commission to Agence Générale des Equipements et Produits de Santé - Etablissement Pharmaceutique des Hôpitaux de Paris (AGEPS - EPHP), France, for 3,4 diaminopyridine phosphate for the treatment of Lambert-Eaton myasthenic syndrome.

The sponsorship was transferred to OPi, France, in April 2006. OPi changed its name to EUSA Pharma SAS in February 2008.

The sponsorship was subsequently transferred to BioMarin Europe Ltd, United Kingdom, in June 2010.

3,4 diaminopyridine phosphate has been authorised in the EU as Firdapse since 23 December 2009.

The sponsorship was transferred to BioMarin International Limited - Ireland, in June 2018.

Key facts

Active substance
3,4-diaminopyridine phosphate
Medicine name
Firdapse
Disease / condition
Treatment of Lambert-Eaton myasthenic syndrome
Date of first decision
19/12/2002
Outcome
Positive
EU designation number
EU/3/02/124

Sponsor's contact details

BioMarin International Limited
Shanbally
Ringaskiddy
County Cork P43 R298
Ireland
E-mail: shanbally@bmrn.com

Patients' organisations

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

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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