🇪🇺 MEROPENEM in European Union

EMA authorised MEROPENEM on 20 November 2018

Marketing authorisation

EMA — authorised 20 November 2018

  • Application: EMEA/H/C/004669
  • Marketing authorisation holder: Menarini International Operations Luxembourg S.A.
  • Local brand name: Vaborem
  • Indication: Vaborem is indicated for the treatment of the following infections in adults: Complicated urinary tract infection (cUTI), including pyelonephritis Complicated intra-abdominal infection (cIAI) Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vaborem is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Consideration should be given to off
  • Status: approved

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MEROPENEM 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 MEROPENEM approved in European Union?

Yes. EMA authorised it on 20 November 2018.

Who is the marketing authorisation holder for MEROPENEM in European Union?

Menarini International Operations Luxembourg S.A. holds the EU marketing authorisation.