Voriconazole Hikma (previously Voriconazole Hospira) (voriconazole)
- Region
- 🇪🇺 EU
- Active substance
- voriconazole
- Company
- Hikma Farmaceutica (Portugal) S.A.
- Status
- Authorised
- Therapeutic area
- Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
- CHMP opinion
- Thu 26 Mar 2015
- EU approval
- Wed 27 May 2015
- Designations
- Generic
- Application
- EMEA/H/C/003737
- 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 2 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 should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Voriconazole Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Vfend Authorised · Pfizer Europe MA EEIG
Follow Voriconazole Hikma (previously Voriconazole Hospira)
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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.