Active substance
Plazomicin
- US FDA 1
- EMA 1
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZEMDRI | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | solution · intravenous | CIPLA USA | Discontinued | 25 Jun 2018 |
EMA European Union — centrally authorised medicines
WHO WHO Model List of Essential Medicines (2025)
- 6.2.3. Reserve group antibiotics · complementary
Carbapenem resistant Acinetobacter baumannii; Carbapenem-resistant Pseudomonas aeruginosa; Other carbapenem resistant Enterobacterales; Carbapenem resistant Escherichia coli; Carbapenem resistant Klebsiella pneumoniae
Parenteral > General injections > IV: 500 mg per 10 mL
Safety signals and safety-related labeling changes
- US FDA 10 Feb 2023 ZEMDRI — safety-related labeling change
Labeling sections changed: Warnings and Precautions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.