🇪🇺 Early Dual IV Antibiotic Therapy - MSSA in European Union

EMA authorised Early Dual IV Antibiotic Therapy - MSSA on 14 October 2016

Marketing authorisations

EMA — authorised 14 October 2016

  • Application: EMEA/H/C/004080
  • Marketing authorisation holder: Hospira UK Limited
  • Local brand name: Ertapenem Hospira
  • Indication: Treatment of bacterial infections and prophylaxis of surgical site infection following elective colorectal surgery.
  • Status: withdrawn

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EMA — authorised 15 July 2022

  • Application: EMEA/H/C/005815
  • Marketing authorisation holder: SUN Pharmaceutical Industries (Europe) B.V.
  • Local brand name: Ertapenem SUN
  • Indication: Treatment Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1): Intra-abdominal infections Community acquired pneumonia Acute gynaecological infections Diabetic foot infections of the skin and soft tissue (see section 4.4) Prevention Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section
  • Status: approved

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Other Infectious Disease approved in European Union

Frequently asked questions

Is Early Dual IV Antibiotic Therapy - MSSA approved in European Union?

Yes. EMA authorised it on 14 October 2016; EMA authorised it on 15 July 2022.

Who is the marketing authorisation holder for Early Dual IV Antibiotic Therapy - MSSA in European Union?

Hospira UK Limited holds the EU marketing authorisation.