EU/3/20/2251: Orphan designation for the treatment of malaria



On 28 February 2020, orphan designation EU/3/20/2251 was granted by the European Commission to YES Pharmaceutical Development Services GmbH, Germany, for artesunate for the treatment of malaria.

The sponsorship was transferred to Amivas Ireland Limited, Ireland in September 2020.

The medicinal product has been authorised in the EU as Artesunate Amivas since 22 November 2021.

Key facts

Active substance
Intended use
Treatment of malaria
Orphan designation status
EU designation number
Date of designation

Amivas Ireland Limited
Durands Court 7
Parnell Street

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Artesunate Amivas at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Update history

22 November 2021The medicinal product has been authorised in the EU as Artesunate Amivas.
September 2020The sponsorship was transferred to Amivas Ireland Limited, Ireland.

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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