EU/3/05/283: Orphan designation for the treatment of idiopathic thrombocytopenic purpura

Recombinant megakaryopoiesis-stimulating protein

Table of contents

Overview

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in February 2019 at the end of the 10-year period of market exclusivity.

On 27 May 2005, orphan designation (EU/3/05/283) was granted by the European Commission to Amgen Europe BV, The Netherlands, for recombinant megakariopoiesis stimulating protein for the treatment of idiopathic thrombocytopenic purpura.

Recombinant megakariopoiesis stimulating protein has been authorised in the EU as Nplate since 4 February 2009.

Key facts

Active substance
Recombinant megakaryopoiesis-stimulating protein
Intended use
Treatment of idiopathic thrombocytopenic purpura
Orphan designation status
Expired
EU designation number
EU/3/05/283
Date of designation
27/05/2005
Sponsor
Amgen Europe BV
Minervum 7061
NL 4817 ZK Breda
The Netherlands
Telephone: +31 12 23 43 61 57
Telefax: +31 12 23 42 68 14
E-mail: regulatory.compliance.elc@amgen.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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