EU/3/18/2065: Orphan designation for the treatment of anthrax

Obiltoxaximab

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
Marie-Curie-Strasse 8 
79539 Loerrach 
Germany
Tel: +49 7621 5500 250
E-mail: office@sfl-services.com

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 PDF icon orphan medicine assessment report .

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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