🇪🇺 Imipenem/Cilastatin/Relebactam in European Union

EMA authorised Imipenem/Cilastatin/Relebactam on 13 February 2020

Marketing authorisation

EMA — authorised 13 February 2020

  • Application: EMEA/H/C/004808
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Recarbrio
  • Indication: Recarbrio is indicated for:- Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1).- Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults.- Treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
  • Status: approved

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Imipenem/Cilastatin/Relebactam in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Imipenem/Cilastatin/Relebactam approved in European Union?

Yes. EMA authorised it on 13 February 2020.

Who is the marketing authorisation holder for Imipenem/Cilastatin/Relebactam in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.