🇪🇺 Isavuconazonium sulfate capsules in European Union

EMA authorised Isavuconazonium sulfate capsules on 15 October 2015

Marketing authorisation

EMA — authorised 15 October 2015

  • Application: EMEA/H/C/002734
  • Marketing authorisation holder: Basilea Pharmaceutica Deutschland GmbH
  • Local brand name: Cresemba
  • Indication: Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Cons
  • Pathway: orphan
  • Status: approved

Read official source →

Isavuconazonium sulfate capsules in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Isavuconazonium sulfate capsules approved in European Union?

Yes. EMA authorised it on 15 October 2015.

Who is the marketing authorisation holder for Isavuconazonium sulfate capsules in European Union?

Basilea Pharmaceutica Deutschland GmbH holds the EU marketing authorisation.