Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Cresemba   
Auth. number : EU/1/15/1036
Active substance : isavuconazole
Orphan market exclusivity for "Treatment of mucormycosis" (based on designation EU/3/14/1276) started on 19/10/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 19/10/2025
Orphan market exclusivity for "Treatment of invasive aspergillosis" (based on designation EU/3/14/1284) started on 19/10/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 19/10/2025
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J02 - Antimycotics for systemic use
Pharmacological subgroup: J02A - Antimycotics for systemic use
Chemical subgroup: J02AC - Triazole derivatives
Chemical substance: J02AC05 - Isavuconazole
(See WHO ATC Index)
Indication: Treatment of
- invasive aspergillosis
- mucormycosis in patients for whom amphotericin B is inappropriate
Consideration should be given to official guidance on the appropriate use of antifungal agents.
Marketing Authorisation Holder: Basilea Medical Ltd
c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/10/2015 Centralised - Authorisation EMEA/H/C/2734 (2015)7201 of 15/10/2015
15/02/2016 Rectificative Decision EMEA/H/C/2734 (2016)933 of 11/02/2016
13/01/2017 Centralised - Variation EMEA/H/C/2734/IB/02