Voriconazole Accord (voriconazole)
- Region
- 🇪🇺 EU
- Active substance
- voriconazole
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Aspergillosis; Candidiasis; Mycoses
- EU approval
- Thu 16 May 2013
- Designations
- Generic
- Application
- EMEA/H/C/002669
- ATC
- J02AC03
- Official record
- www.ema.europa.eu
Indication
Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Voriconazole Hikma (previously Voriconazole Hospira) Authorised · Hikma Farmaceutica (Portugal) S.A.
- 🇪🇺 Vfend Authorised · Pfizer Europe MA EEIG
Follow Voriconazole Accord
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.