FDA — authorised 16 July 2019
- Application: NDA212819
- Marketing authorisation holder: MSD MERCK CO
- Local brand name: RECARBRIO
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Imipenem/Cilastatin/Relebactam in United States
FDA authorised Imipenem/Cilastatin/Relebactam on 16 July 2019 · 2 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 2
Most-reported reactions
- Adverse Drug Reaction — 1 report (50%)
- Liver Function Test Increased — 1 report (50%)
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 United States
Frequently asked questions
Is Imipenem/Cilastatin/Relebactam approved in United States?
Yes. FDA authorised it on 16 July 2019.
Who is the marketing authorisation holder for Imipenem/Cilastatin/Relebactam in United States?
MSD MERCK CO holds the US marketing authorisation.