Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Voriconazole Accord   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Вориконазол Accord (BG)
   - Voriconazol Accord (DE)
   - Voriconazol Accord (ES)
   - Voriconazolo Accord (IT)
   - Voriconazol Accord (NL)
   - Voriconazol Accord (PT)
   - Vorikonazol Accord (SL)
Auth. number : EU/1/13/835
INN : voriconazole
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: J02AC03 - Voriconazole
(See WHO ATC Index)
Indication: Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Treatment of invasive aspergillosis.
Treatment of candidemia in non-neutropenic patients.
Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).
Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Marketing Authorisation Holder: Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, 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
22/05/2013 Centralised - Authorisation EMEA/H/C/2669 (2013)2992 of 16/05/2013
18/10/2013 Centralised - Variation EMEA/H/C/2669/IB/3
Updated with Decision(2014)7192 of 01/10/2014
20/12/2013 Centralised - Variation EMEA/H/C/2669/IAin/4
Updated with Decision(2014)7192 of 01/10/2014
03/10/2014 Centralised - Yearly update (2014)7192 of 01/10/2014