Recarbrio (imipenem;cilastatin;relebactam)
- Region
- 🇪🇺 EU
- Active substance
- imipenem;cilastatin;relebactam
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Gram-Negative Bacterial Infections
- CHMP opinion
- Thu 12 Dec 2019
- EU approval
- Thu 13 Feb 2020
- Application
- EMEA/H/C/004808
- ATC
- J01DH56
- Official record
- www.ema.europa.eu
Indication
Recarbrio is indicated 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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.