Anpheros Search · Treatment

Anidulafungin

Also known as: Ecalta · ERAXIS

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In short

In the European Union, anidulafungin is indicated for the treatment of invasive candidiasis in adults and paediatric patients aged 1 month to less than 18 years. In the United States, it is indicated for the treatment of candidemia and other forms of Candida infections, specifically intra-abdominal abscess and peritonitis, in adults and pediatric patients aged 1 month and older, as well as for esophageal candidiasis in adults. The medication is also listed by the cited source as having an approved use for candidiasis.

From: Source: European Medicines Agency (EMA), Ecalta — EPAR, 09/09/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
341018 anidulafungin
EMA
EMEA/H/C/000788

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Ecalta

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years.

Source: European Medicines Agency (EMA), Ecalta — EPAR, 09/09/2025. © European Medicines Agency.

Document date: 09/09/2025 · Official document →

FDA (USA) ERAXIS

1 INDICATIONS AND USAGE ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) ( 1.1 ) • Esophageal candidiasis in adults ( 1.2 ) Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. ( 1.3 , 5.3 , 8.4 ) • ERAXIS is associated with high relapse rates in esophageal candidiasis. ( 1.3 , 14.2 ) 1.1 Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis) ERAXIS is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis in adults and pediatric patients 1 month of age and older [see Clinical Studies (14.1) and Microbiology (12.4) ] . 1.2 Esophageal Candidiasis ERAXIS is indicated for the treatment of esophageal candidiasis in adults [see Indications and Usage (1.3) , Clinical Studies (14.2) ] . 1.3 Limitations of Use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida , and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established [see Warning and Precautions (5.3) , Use in Specific Populations (8.4) ] . • ERAXIS is associated with high relapse rates in esophageal candidiasis [see Clinical Studies (14.2) ] . 1.4 Usage Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

Data provided by the U.S. Food and Drug Administration.

Document date: 20250819 · Official document →

Related terms in the cited sources

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What people report

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External resources

Questions

What is Anidulafungin approved for in the European Union?

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years. (Source: European Medicines Agency (EMA), Ecalta — EPAR, 09/09/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Ecalta — EPAR, 09/09/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →