EU/3/01/039: Orphan designation for the treatment of soft tissue sarcoma

Ecteinascidin 743 (trabectedin)

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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2017 at the end of the 10-year period of market exclusivity.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 30 May 2001, orphan designation (EU/3/01/039) was granted by the European Commission to Pharma Mar SA, Spain, for ecteinascidin 743 for the treatment of soft tissue sarcoma.

Ecteinascidin 743 in treatment of soft tissue sarcoma has been authorised in the EU as Yondelis since 17 September 2007.

This medicine is now known as trabectedin.

Key facts

Active substance
Ecteinascidin 743 (trabectedin)
Medicine name
Intended use
Treatment of soft tissue sarcoma
Orphan designation status
EU designation number
Date of designation
PharmaMar S.A.
Polígono Industrial La Mina
Av. de los Reyes 1
28770 Colmenar Viejo
Telephone: (34-91) 846 60 00
Telefax: (34-91) 823 45 03

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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