EU/3/20/2251: Orphan designation for the treatment of malaria
artesunate
Table of contents
Overview
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 |
artesunate
|
Intended use |
Treatment of malaria
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/20/2251
|
Date of designation |
28/02/2020
|
Sponsor |
Amivas Ireland Limited |
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
orphan medicine assessment report
.
Update history
Date | Update |
---|---|
22 November 2021 | The medicinal product has been authorised in the EU as Artesunate Amivas. |
September 2020 | The sponsorship was transferred to Amivas Ireland Limited, Ireland. |
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: