Extended indication Eravacycline monotherapy for treatment of Complicated intra-abdominal infection in children and adolescents.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Eravacycline
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Eravacycline monotherapy for treatment of Complicated intra-abdominal infection in children and adolescents.
Proprietary name Xerava
Manufacturer PAION
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Is nauw gerelateerd aan tigecycline en tetracyclines met werkzaamheid tegen meticilline resistente Staphylococcus aureus (MRSA) en carbapenem resistente enterobacteriaceae.

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP No
Submission date April 2025
Expected Registration February 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.

References NCT06794541

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information