EU/3/14/1383: Orphan designation for the treatment of pleural empyema

Single-chain urokinase plasminogen activator


On 16 December 2014, orphan designation (EU/3/14/1383) was granted by the European Commission to Coté Orphan Consulting UK Limited, United Kingdom, for single-chain urokinase plasminogen activator for the treatment of pleural empyema.

The sponsorship was transferred to IQVIA RDS Ireland Limited, Ireland, in May 2018.

The sponsorship was transferred to Scendea (NL) B.V., Netherlands in September 2021.

Key facts

Active substance
Single-chain urokinase plasminogen activator
Intented use
Treatment of pleural empyema
Orphan designation status
EU designation number
Date of designation

Scendea (NL) B.V.
De Cuserstraat 93 
1081 CN Amsterdam  

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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