Rezzayo (rezafungin)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rezafungin
- Company
- Mundipharma GmbH
- Status
- Authorised
- Therapeutic area
- Candidiasis; Candidiasis, Invasive
- CHMP opinion
- Thu 12 Oct 2023
- EU approval
- Fri 22 Dec 2023
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005900
- ATC
- J02AX08
- Official record
- www.ema.europa.eu
Indication
Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.
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.