Imipenem / Cilastatin / Relebactam (3) – Recarbrio®

Bacterial infections, multiple therapeutic indications, under 18 years of age

Characteristics

Start date 15.02.2026 – Marketing authorisation: 19.01.2026
Resolution 06.08.2026
INN Imipenem/Cilastatin/Relebactam
Brand name Recarbrio®
Pharm. company MSD Sharp & Dohme GmbH
G-BA Procedure ID D-1281
Therapeutic area Infectious diseases
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

Recarbrio is indicated in paediatric patients from birth for:

- The treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). - The treatment of bacteraemia that is associated with, or suspected to be associated with, HAP or VAP. - The treatment of infections caused by aerobic Gram-negative pathogens for which treatment options are limited.

Official guidelines on the appropriate use of antibiotics must be followed.
Subpopulation Indication Comparator
c) Paediatric patients under 18 years of age with infections caused by aerobic Gram-negative pathogens for which treatment options are limited
a) Paediatric patients under 18 years of age with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
b) Paediatric patients under 18 years of age with bacteraemia that is known or suspected to be associated with HAP or VAP

Studies and Results

  • Clinical trials
    • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/relbactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of the German Social Code, Book V (SGB V) was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.

a) Paediatric patients under 18 years of age with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/relebactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee (G-BA) has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

b) Paediatric patients under 18 years of age with bacteraemia for which a link to HAP or VAP exists or is suspected

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/relebactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed to have been proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

c) Paediatric patients under 18 years of age with infections caused by aerobic Gram-negative pathogens for which treatment options are limited

  • The additional benefit is deemed proven.
  • For the medicinal product Recarbrio, containing the combination of active substances imipenem/cilastatin/relebactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, numbers 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
  • Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).

Courtesy translation only, please refer to the German original.

Associated procedures



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