Nyxthracis (previously Obiltoxaximab SFL)
obiltoxaximab
Table of contents
Overview
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.
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Obiltoxaximab SFL : EPAR - Medicine overview (PDF/114.8 KB)
First published: 27/11/2020
EMA/506632/2020 -
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Obiltoxaximab SFL : EPAR - Risk-management-plan summary (PDF/39.92 KB)
First published: 27/11/2020
Authorisation details
Product details | |
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Name |
Nyxthracis (previously Obiltoxaximab SFL)
|
Agency product number |
EMEA/H/C/005169
|
Active substance |
nyxthracis
|
International non-proprietary name (INN) or common name |
obiltoxaximab
|
Therapeutic area (MeSH) |
Anthrax
|
Anatomical therapeutic chemical (ATC) code |
J06BB22
|
Additional 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 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. |
Orphan |
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 | |
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Marketing-authorisation holder |
SFL Pharmaceuticals Deutschland GmbH
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Revision |
3
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Date of issue of marketing authorisation valid throughout the European Union |
18/11/2020
|
Contact address |
SFL Pharmaceuticals Deutschland GmbH |
Product information
14/12/2022 Nyxthracis (previously Obiltoxaximab SFL) - EMEA/H/C/005169 - IAIN/0009
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).