EMA European Union — centrally authorised medicines
Cresemba Basilea Pharmaceutica Deutschland GmbH · Authorised · authorised 15 Oct 2015 · ATC J02AC05
Therapeutic indication (EMA)
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) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| CRESEMBA | 02483971 | 100 MG | CAPSULE · ORAL | AVIR PHARMA INC. |
| CRESEMBA | 02483998 | 200 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | AVIR PHARMA INC. |
| CRESEMBA | 02553279 | 40 MG | CAPSULE · ORAL | AVIR PHARMA INC. |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.