Nyxthracis (previously Obiltoxaximab SFL)



This medicine is authorised for use in the European Union.


Obiltoxaximab SFL is a medicine used with antibiotic treatment to treat inhalational anthrax, a serious disease caused by the bacteria Bacillus anthracis. ‘Inhalational’ means that the person catches the disease by breathing in spores, which develop into active bacteria in the body and release harmful toxins.

The medicine is also used to prevent inhalational anthrax in people who have come into contact with the bacteria spores and when no other appropriate treatment is available.

Obiltoxaximab SFL contains the active substance obiltoxaximab.

Anthrax is rare, and Obiltoxaximab SFL was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 August 2018.

This EPAR was last updated on 15/12/2022

Authorisation details

Product details
Nyxthracis (previously Obiltoxaximab SFL)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
SFL Pharmaceuticals Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

SFL Pharmaceuticals Deutschland GmbH
Marie-Curie-Strasse 8
79539 Lörrach

Product information

14/12/2022 Nyxthracis (previously Obiltoxaximab SFL) - EMEA/H/C/005169 - IAIN/0009

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Obiltoxaximab SFL is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis (see section 5.1).

Obiltoxaximab SFL is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.1).

Assessment history

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