Key facts

Invented name
Recarbrio
Active Substance
  • relebactam (MK-7655A)
  • cilastatin sodium
  • imipenem monohydrate
Therapeutic area
Infectious diseases
Decision number
P/0279/2020
PIP number
EMEA-001809-PIP01-15-M02
Pharmaceutical form(s)
Powder for solution for infusion
Condition(s) / indication(s)
Treatment of Gram-negative bacterial infections
Route(s) of administration
Parenteral use
Contact for public enquiries

Merck Sharp & Dohme (Europe), Inc.

Tel. +33 180464738
Email: pip.information@merck.com

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0279/2020: EMA decision of 24 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for imipenem (monohydrate) / cilastatin (sodium) / relebactam (MK-7655A) (Recarbrio), (EMEA-001809-PIP01-15-M02)

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