Ertapenem Pd.C.So.In 1g/Vial (under development)
Reference Product: Invanz® / MSD
Description: Ertapenem is a Carbapenem Antibiotic indicated in paediatric patients and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to Ertapenem and when parenteral therapy is required:• Intra-abdominal infections• Community acquired pneumonia• Acute gynecological infections• Diabetic foot infections of the skin and soft tissue Ertapenem is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery
Dossier Status: Ongoing / Timelines to be defined
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Two (2) years
Batch Size: To be defined
Pack Sizes: To be defined / Originator pack: Box x 1 or 10 vial(s)
|Categories||Generic APIsGeneric Antibiotics; Finished Dosage FormsInjectables; Finished Dosage FormsOut-licensing|
|Sales markets||Middle East Region (e.g. UAE); Oceania; North America (USA, Canada); Africa; Central America (e.g. Mexico); Europe - EU countries; Europe - non EU (e.g. UK, Russia, ex-CIS countries); South America (e.g. Brazil, Colombia); South East Asia (e.g. Thailand, Philippines, Singapore)|
|Selling Points||International Approvals/Standards|
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