EMEA-001809-PIP01-15-M05 - paediatric investigation plan
imipenem monohydrate
cilastatin sodium
relebactam (MK-7655A)
PIPHuman
Key facts
- Invented name
- Recarbrio
- Active Substance
- imipenem monohydrate
- cilastatin sodium
- relebactam (MK-7655A)
- Therapeutic area
- Infections and infestations
- Decision number
- P/0190/2024
- PIP number
- EMEA-001809-PIP01-15-M05
- Pharmaceutical form(s)
- Powder for solution for infusion
- Condition(s) / indication(s)
- Treatment of infections caused by gram-negative organisms
- Route(s) of administration
- Parenteral use
- Contact for public enquiries
Merck Sharp & Dohme (Europe) Inc.
Tel.: +33180464738
E-mail: pip.information@merck.com- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date