🇪🇺 daptomycin and gentamicin in European Union

EMA authorised daptomycin and gentamicin on 19 January 2006

Marketing authorisation

EMA — authorised 19 January 2006

  • Application: EMEA/H/C/000637
  • Local brand name: Cubicin
  • Indication: Cubicin is indicated for the treatment of the following infections. Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI). Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or
  • Status: approved

Read official source →

daptomycin and gentamicin 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 daptomycin and gentamicin approved in European Union?

Yes. EMA authorised it on 19 January 2006.

Who is the marketing authorisation holder for daptomycin and gentamicin in European Union?

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the originator. The local marketing authorisation holder may differ — check the official source linked above.