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Micafungin

Mycamine · ATC code J02AX05

Also known as: Mikafungin · Brand names: Mycamine, Micafungin Biocon, Micafungin Hikma, Micafungin Pharmazac, Micafungin Ratiopharm, Mifundex, Mikafungus, Mixagin, Msfungin, Myacit, Myafung

Key facts
Active substance
Micafungin
ATC code
J02AX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Mycamine 50 mg powder for concentrate for solution for infusion / Mycamine 100 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Sandoz Pharmaceuticals d.d.
Information as of
2026-10-29

Key facts

Micafungin (Mycamine) is an intravenous echinocandin antifungal used to treat and prevent Candida infections in adults and children, including neonates.

What it is used for

  • Adults and adolescents ≥ 16 years: invasive candidiasis, oesophageal candidiasis (when intravenous therapy is appropriate), and prophylaxis of Candida infection in allogeneic stem cell transplantation or expected neutropenia (< 500 cells/µl) for 10 or more days.
  • Children (including neonates) and adolescents < 16 years: invasive candidiasis and Candida prophylaxis.
  • Because of a potential risk of liver tumours, use only if other antifungals are not appropriate.

Dosing

  • Adults, over 40 kg: invasive candidiasis 100 mg/day (up to 200 mg/day if response is inadequate), oesophageal candidiasis 150 mg/day, prophylaxis 50 mg/day.
  • Adults, 40 kg or less: 2 mg/kg/day (up to 4 mg/kg/day), 3 mg/kg/day and 1 mg/kg/day respectively.
  • Children from 4 months: as adults, without the oesophageal candidiasis indication; children under 4 months: invasive candidiasis 4 -10 mg/kg/day, prophylaxis 2 mg/kg/day.
  • Invasive candidiasis for at least 14 days and at least one week after two negative blood cultures; prophylaxis until at least one week after neutrophil recovery.

Contraindications

  • Hypersensitivity to the active substance, other echinocandins or any excipient.

Important warnings

  • Liver tumours in rats after 3 months or longer; clinical relevance unknown. Monitor liver function carefully and stop early with persistent ALT/AST elevation.
  • Serious hepatic dysfunction up to hepatic failure (including fatal cases) reported; children under 1 year may be more prone to liver injury.
  • Anaphylactic reactions including shock may occur.
  • Haemolysis and haemolytic anaemia may occur.

Side effects

  • In clinical trials 32.2% of patients had adverse reactions.
  • Most frequent: nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%), vomiting (2.5%) and AST increased (2.3%).
  • Common: leukopenia, neutropenia, anaemia; rare: haemolytic anaemia; anaphylactic shock possible.

Interactions

  • Low interaction potential; no micafungin dose adjustment with ciclosporin, tacrolimus, fluconazole, rifampicin and others.
  • Exposure of itraconazole, sirolimus and nifedipine is slightly increased (22%, 21% and 18%).

Pregnancy and breastfeeding

  • Should not be used during pregnancy unless clearly necessary.
  • Breast-feeding: weigh breast-feeding against therapy.

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 →

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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)

  • MycamineSandoz Pharmaceuticals d.d. · EMEA/H/C/000734

Source: European Medicines Agency (EMA), product information

Austria

  • Micafungin BioconBiocon Pharma Malta I Limited · 1 register entry
  • Micafungin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Micafungin PharmazacPharmazac Sa · 1 register entry
  • Micafungin RatiopharmTeva B.V · 1 register entry

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

Germany

  • MicafunginInresa Arzneimittel Gmbh, Pharmore Gmbh, Hikma Farmacêutica (Portugal), S.A. · 4 register entries

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

Turkey

  • MifundexGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries
  • MikafungusPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MixaginCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MsfunginHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MyacitVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MyafungSABA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • MycamineSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

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

Brand names in 26 more European countries
Belgium
Micafungine Hikma
Bulgaria
Микафунгин Tzf, Микафунгин Ромфарм
Croatia
Micafungin Accord, Mikafungin Pharmazac, Mikafungin Teva, Mikafungin Tzf
Cyprus
Micafungin Accord, Micafungin Pharmazac
Czechia
Micafungin Accord, Micafungin Agmed, Micafungin Olikla, Micafungin Teva
Denmark
Micafungin ”hikma”
Estonia
Micafungin Pharmazac, Micafungin Tzf
Finland
Micafungin Accord, Micafungin Hikma
France
Micafungine Accord, Micafungine Hikma, Micafungine Pharma D&s, Micafungine Reig Jofre, Micafungine Viatris
Greece
Funzoren, Micafungin Anfarm, Micafungin Pharmazac, Micafungin Teva, Viamic
Hungary
Micafungin Pharma D&s, Micafungin Pharmazac, Micafungin Rompharm, Micafungin Teva, Mikafungin Accord
Iceland
Mycamine
Italy
Micafungina Accord, Micafungina Hikma, Micafungina Pharma D&s, Micafungina Reig Jofre, Micafungina Teva
Latvia
Micafungin Accord, Micafungin Pharmazac, Micafungin Tzf
Liechtenstein
Mycamine
Lithuania
Micafungin Accord, Micafungin Pharmazac, Micafungin Tzf
Malta
Funzoren, Micafungin Anfarm, Micafungin Sandoz
Netherlands
Micafungin Pharmazac, Micafungine Accord, Micafungine Biocon, Micafungine Hikma, Micafungine Pharma D&s, Micafungine Pharmazac, Micafungine Teva, Micafungine Viatris
Norway
Micafungin Accord, Micafungin Hikma, Micafungin Viatris, Mycamine
Poland
Micafungin Accord, Micafungin Pharmazac, Micafungin Pharmline, Micafungin Reig Jofre, Micafungin Teva, Micafungin Viatris, Mykafungina Accordpharma
Portugal
Micafungin Accordpharma, Micafungina Accord, Micafungina Accordpharma, Micafungina Hikma, Micafungina Mylan, Micafungina Reig Jofre, Micafungina Teva, Micafungina Tzf
Romania
Micafungin Pharmazac, Micafungin Rompharm
Slovakia
Micafungin Accord, Micafungin Olikla
Slovenia
Mikafungin Accord, Mikafungin Pharmazac, Mikafungin Teva
Spain
Micafungina Accord, Micafungina Accordpharma, Micafungina Hikma, Micafungina Macleods, Micafungina Pharma D&s, Micafungina Sala, Micafungina Sandoz, Micafungina Teva
Sweden
Micafungin Accord, Micafungin Bioglan, Micafungin Hikma, Micafungin Mylan, Micafungin Viatris, Mikafungin Teva

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.

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Sources

  1. European Medicines Agency. Mycamine – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/mycamine-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 2026-10-29 · 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.