Nyxthracis (previously Obiltoxaximab SFL) (obiltoxaximab)
- Region
- 🇪🇺 EU
- Active substance
- obiltoxaximab
- Company
- SFL Pharmaceuticals Deutschland GmbH
- Status
- Withdrawn
- Therapeutic area
- Anthrax
- CHMP opinion
- Thu 17 Sep 2020
- EU approval
- Wed 18 Nov 2020
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005169
- ATC
- J06BB22
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.