Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 04 August 2017

Indication(s)

- Treatment of invasive candidiasis in adult or paediatric patients.
- Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole.
   Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
- Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.

 

Full Prescribing information

Learning Zones

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Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis.

Background: Mucormycosis is an uncommon invasive fungal disease with high mortality and few treatment options. Isavuconazole is a triazole active...

Added 2 years ago

Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial

Background: Isavuconazole is a novel triazole with broad-spectrum antifungal activity. The SECURE trial assessed efficacy and safety of isavuconazole versus...

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Postantifungal Effect of Micafungin against the Species Complexes of Candida albicans and Candida parapsilosis.

Micafungin is an effective antifungal agent useful for the therapy of invasive candidiasis. Candida albicans is the most common cause...

Added 3 years ago

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Guidelines

ESCMID guideline for the diagnosis and management of Candida diseases 2012: prevention and management of invasive infections in neonates and children caused by Candida spp.

Invasive candidiasis (IC) is a relatively common syndrome in neonates and children and is associated with significant morbidity and mortality....

Added 5 years ago

British Association of Dermatologists’ guidelines for the management of tinea capitis 2014

The overall objective of this guideline is to provide up-todate, evidence-based recommendations for the management of tinea capitis.

Added 4 years ago

ESCMID and ECMM joint guidelines on diagnosis and management of hyalohyphomycosis: Fusarium spp., Scedosporium spp. and others

The overall aim of this guidance is to address the difficulties in managing and diagnosing invasive fungal infections due to hyalohyphomycetes.

Added 4 years ago

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More information

Category Value
Agency product number EMEA/H/C/000379
Orphan designation No
Date First Approved 24-10-2001
Type POM
Marketing authorisation holder Merck Sharp & Dohme Ltd.