Recarbrio - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

imipenem / cilastatin / relebactam

Opinion

On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Recarbrio. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.

The CHMP adopted an extension to the existing indication, as follows:

Recarbrio is indicated in adult and paediatric patients from birth 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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Recarbrio (EMA/VR/0000265089)

Adopted Reference Number: EMADOC-1700519818-2608675

Key facts

• Name of medicine:
  Recarbrio
• EMA product number:
  EMEA/H/C/004808
• Active substance:
  • imipenem monohydrate
  • cilastatin sodium
  • relebactam monohydrate
• International non-proprietary name (INN) or common name:
  • imipenem
  • cilastatin
  • relebactam
• Therapeutic area (MeSH):
  Gram-Negative Bacterial Infections
• Anatomical therapeutical chemical (ATC) code:
  J01DH56
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.
• Date of opinion:
  11/12/2025
• Status:
  Positive