EU/3/01/035: Orphan designation for the treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations

levodopa / carbidopa

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2015.

The first country to approve Duodopa was Sweden in January 2004. On 18 November 2005 Duodopa was approved by all 25 EU Member States. Duodopa was the last orphan medicinal product to be approved through the Mutual Recognition Procedure (MRP).

On 10 May 2001, orphan designation (EU/3/01/035) was granted by the European Commission to NeoPharma Production AB, Sweden, for levodopa / carbidopa (gastroenteral use) for the treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations and not responding to oral treatment.

The sponsorship was transferred to Solvay Pharmaceuticals GmbH, Germany, in March 2006.

The sponsor changed name to Abbott Products GmbH in November 2010.

The sponsorship was transferred to AbbVie Ltd, United Kingdom, in February 2013.

Key facts

Active substance
  • levodopa
  • carbidopa
Intended use
Treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations
Orphan designation status
Withdrawn
EU designation number
EU/3/01/035
Date of designation
10/05/2001
Sponsor
AbbVie Ltd
Vanwall Business Park
Vanwall Road
Maidenhead
Berkshire SL6 4XE
United Kingdom
Tel. +44 (0)1628 644501
Fax +44 (0)1628 672624
E-mail: orphandrugs.enquiries@abbvie.com

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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