Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Zinforo   
Auth. number : EU/1/12/785
INN : ceftaroline fosamil
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01D - Other beta-lactam antibacterials
Chemical subgroup: J01DI - Other cephalosporins
Chemical substance: J01DI02 - Ceftaroline fosamil
(See WHO ATC Index)
Indication: Zinforo is indicated in adults for the treatment of the following infections:
  • Complicated skin and soft tissue infections (cSSTI)
  • Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marketing Authorisation Holder: AstraZeneca AB
SE-151 85 Södertälje, Sverige

  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
27/08/2012 Centralised - Authorisation EMEA/H/C/2252 (2012)6016 of 23/08/2012
21/11/2013 Centralised - Variation EMEA/H/C/2252/II/4
Updated with Decision(2014)8293 of 30/10/2014
08/07/2014 Centralised - Variation EMEA/H/C/2252/IB/13
Updated with Decision(2014)8293 of 30/10/2014
24/07/2014 Centralised - Variation EMEA/H/C/2252/IA/18
Updated with Decision(2014)8293 of 30/10/2014
25/09/2014 Centralised - Variation EMEA/H/C/2252/II/17
Updated with Decision(2014)8293 of 30/10/2014
25/09/2014 Centralised - Variation EMEA/H/C/2252/II/14
Updated with Decision(2014)8293 of 30/10/2014
03/11/2014 Centralised - 2-Monthly update EMEA/H/C/2252/II/16 (2014)8293 of 30/10/2014