MedeliX
Start asking

posaconazole

Noxafil · ATC code J02AC04

Also known as: Posaconazol, Posakonazol · Brand names: Noxafil, Posaconazol Altan, Posaconazol Ratiopharm, Posaconazol Stada, Ossmiq, Fugafyl, Mspos, Pansoril, Posagil, Posaksin, Posdizol, Posectio

Key facts
Active substance
posaconazole
ATC code
J02AC04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Noxafil 40 mg/mL oral suspension · Noxafil 100 mg gastro-resistant tablets · Noxafil 300 mg concentrate for solution for infusion · Noxafil 300 mg gastro-resistant powder and solvent for oral suspension
Marketing authorisation holder
Merck Sharp and Dohme B.V
Information as of
2026-10-28

Key facts

Posaconazole (Noxafil) is a triazole antifungal used to treat invasive and other serious fungal infections and to prevent invasive fungal infections in high-risk patients.

What it is used for

  • Treatment of invasive aspergillosis (tablets, infusion, powder for suspension; oral suspension only when refractory or intolerant to amphotericin B or itraconazole).
  • Fusariosis, chromoblastomycosis/mycetoma and coccidioidomycosis refractory to or intolerant of standard therapy.
  • Oral suspension only: oropharyngeal candidiasis as first-line therapy in severe disease or immunocompromised patients.
  • Prophylaxis of invasive fungal infections in high-risk patients, e.g. during remission-induction chemotherapy for AML or MDS, or in HSCT recipients on high-dose immunosuppression for GVHD.

Dosing

  • Formulations are not interchangeable; the dose for each formulation must be followed.
  • Noxafil 100 mg gastro-resistant tablets (adults and children from 2 years over 40 kg): loading dose 300 mg twice a day on the first day, then 300 mg once a day, with or without food; invasive aspergillosis 6-12 weeks.
  • Noxafil 300 mg concentrate for infusion: adults 300 mg twice a day on the first day, then 300 mg once a day; children 2 to less than 18 years 6 mg/kg (maximum 300 mg) on the same schedule; via a central venous line over approximately 90 minutes.
  • Noxafil 40 mg/mL oral suspension (adults only), with or after a meal: refractory infections 200 mg four times a day or 400 mg twice a day; prophylaxis 200 mg three times a day; oropharyngeal candidiasis 200 mg on the first day, then 100 mg once a day for 13 days.
  • Noxafil gastro-resistant powder for oral suspension (children 2 to <18 years, 10 to 40 kg): 90 mg to 240 mg by weight, twice on Day 1 and once daily thereafter.
  • No adjustment in renal impairment; caution in hepatic impairment due to higher exposure.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.
  • Co-administration with ergot alkaloids, with terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine (QTc prolongation, torsade de pointes), or with simvastatin, lovastatin and atorvastatin.
  • Co-administration during the initiation and dose-titration phase of venetoclax in CLL.

Important warnings

  • Hepatic reactions, rarely fatal; liver function tests before and during treatment, and caution in hepatic impairment.
  • QTc prolongation; caution in patients with proarrhythmic conditions (see the full text).
  • Caution in patients with hypersensitivity to other azoles.
  • Flucloxacillin and other inducers may lower posaconazole levels.

Side effects

  • Very common: nausea.
  • Common: neutropenia, vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation.
  • Serious related reactions most often reported: nausea, vomiting, diarrhoea, pyrexia, increased bilirubin.
  • Rare: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, adrenal insufficiency, pseudoaldosteronism, pulmonary hypertension.

Interactions

  • Inhibitors of UDP glucuronidation or P-gp (e.g. verapamil, ciclosporin, clarithromycin) may increase, and inducers (e.g. rifampicin, rifabutin, certain anticonvulsants) decrease posaconazole levels; rifabutin reduced posaconazole AUC to 51 %.
  • Flucloxacillin should be avoided unless the benefit outweighs the risk.
  • Posaconazole raises levels of many CYP3A4 substrates.

Pregnancy and breastfeeding

  • Must not be used during pregnancy unless the benefit clearly outweighs the risk; effective contraception during treatment.
  • Breast-feeding must be stopped when treatment starts.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Posaconazol AltanAltan Pharmaceuticals S.A. · 1 register entry
  • Posaconazol RatiopharmTeva B.V · 1 register entry
  • Posaconazol StadaStada Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • OssmiqHexal Ag · 1 register entry
  • PosaconazolAliud Pharma Gmbh, Vivanta Generics S.R.O., Ratiopharm Gmbh, Glenmark Arzneimittel Gmbh, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Zentiva Pharma Gmbh, Accord Healthcare B.V., Amarox Pharma Gmbh, Axunio Pharma Gmbh, Biocon Pharma Malta I Limited, Hexal Ag, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Abdi Farma Gmbh, Betapharm Arzneimittel Gmbh · 21 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • FugafylDEVA HOLDİNG A.Ş. · 2 register entries
  • MsposHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • NoxafilMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 4 register entries
  • PansorilSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PosagilABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • PosaksinFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • PosdizolNOBEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PosectioPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 25 more European countries
Belgium
Posaconazol Sandoz, Posaconazole Ab, Posaconazole Teva
Croatia
Posakonazol Abdi, Posakonazol Msn, Posakonazol Stada, Posakonazol Teva, Posakonazol Viatris, Posakonazol Zentiva
Czechia
Gudivin, Posaconazole Accord, Posaconazole Msn, Posaconazole Sandoz, Posaconazole Teva Pharma, Posaconazole Zentiva, Posakonazol Abdi
Denmark
Posaconazol Stada, Posaconazol Teva B.V., Posaconazol Viatris, Posaconazole "sandoz", Posaconazole Amarox, Posaconazole Sandoz, Posaconazole Stada, Posaconazole Vivanta
Estonia
Ossmiq, Posaconazol, Posaconazole Viatris
Finland
Posaconazol Vivanta, Posaconazole
France
Posaconazole Accord, Posaconazole Altan, Posaconazole Amarox, Posaconazole Arrow, Posaconazole Elc, Posaconazole Kabi, Posaconazole Olpha, Posaconazole Tillomed, Posaconazole Viatris, Posaconazole Zentiva
Greece
Posaconazole Genepharm, Posaconazole Stada
Hungary
Gudivin, Posaconazol Accord, Posaconazol Teva, Posaconazole Genepharm, Posaconazole Msn
Iceland
Noxafil, Posaconazole Accord, Posaconazole Ahcl, Posaconazole Stada
Ireland
Posaconazole
Italy
Posaconazole Eg Stada, Posaconazole Mylan, Posaconazolo Abdi, Posaconazolo Aurobindo, Posaconazolo Biocon, Posaconazolo Eg, Posaconazolo Fresenius Kabi, Posaconazolo Mylan Pharma, Posaconazolo Teva, Posaconazolo Tillomed, Posaconazolo Zentiva
Latvia
Posaconazole Stada
Liechtenstein
Noxafil, Posaconazole Accord, Posaconazole Ahcl
Lithuania
Posaconazole Stada
Malta
Posaconazole
Netherlands
Posaconazol
Norway
Noxafil, Posaconazole Accord, Posaconazole Ahcl, Posaconazole Viatris, Posaconazole Vivanta
Poland
Posaconazole Accord, Posaconazole Aurovitas, Posaconazole Glenmark, Posaconazole Msn, Posaconazole Sandoz, Posaconazole Stada, Posaconazole Teva, Posaconazole Viatris, Pozakonazol Altan
Portugal
Posaconazol Almovar, Posaconazol Anfarm, Posaconazol Generis, Posaconazol Inventia, Posaconazol Msn, Posaconazol Mylan, Posaconazol Sandoz, Posaconazol Viatris
Romania
Posaconazol
Slovakia
Posaconazol Msn, Posaconazole Msn, Posaconazole Sandoz, Posaconazole Stada, Posaconazole Zentiva, Posakonazol Stada, Posakonazol Teva
Slovenia
Posaconazol Msn, Posakonazol Stada, Posakonazol Teva
Spain
Posaconazol
Sweden
Posaconazole

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Noxafil – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/noxafil-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.