EU/3/02/121: Orphan designation for the intra-operative photodynamic diagnosis of residual glioma

5-aminolevulinic acid hydrochloride

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2017 at the end of the 10-year period of market exclusivity.

On 13 November 2002, orphan designation (EU/3/02/121) was granted by the European Commission to medac Gesellschaft für klinische Spezialpräparate mbH, Germany, for 5-aminolevulinic acid hydrochloride for the intra-operative photodynamic diagnosis of residual glioma.

5-aminolevulinic acid hydrochloride has been authorised in the EU as Gliolan since 7 September 2007.

Key facts

Active substance
5-aminolevulinic acid hydrochloride
Medicine name
Gliolan
Intended use
Intra-operative photodynamic diagnosis of residual glioma
Orphan designation status
Expired
EU designation number
EU/3/02/121
Date of designation
14/11/2002
Sponsor

medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6
D-22880 Wedel
Germany
Tel. + 49 4103 8006 0
Fax + 49 4103 8006 100
E-mail: contact@medac.de

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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