Cresemba (isavuconazole)
- Region
- 🇪🇺 EU
- Active substance
- isavuconazole
- Company
- Basilea Pharmaceutica Deutschland GmbH
- Status
- Authorised
- Therapeutic area
- Aspergillosis
- CHMP opinion
- Sat 23 Jul 2005
- EU approval
- Thu 15 Oct 2015
- Designations
- Orphan
- Application
- EMEA/H/C/002734
- ATC
- J02AC05
- Official record
- www.ema.europa.eu
Indication
Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients.
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.