EU/3/18/2065: Orphan designation for the treatment of anthrax
Obiltoxaximab
Table of contents
Overview
On 24 August 2018, orphan designation (EU/3/18/2065) was granted by the European Commission to SFL Regulatory Services GmbH, Austria, for obiltoxaximab for the treatment of anthrax.
The sponsorship was transferred to SFL Pharmaceuticals Deutschland GmbH, Germany, in July 2020.
Obiltoxaximab has been authorised in the EU as Obiltoxaximab SFL since 18 November 2020.
Key facts
Active substance |
Obiltoxaximab
|
Intended use |
Treatment of anthrax
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/18/2065
|
Date of designation |
24/08/2018
|
Sponsor |
SFL Pharmaceuticals Deutschland GmbH |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Obiltoxaximab SFL 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
.
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: