Eravacycline Medicine 03 June 2025 Extended indication Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI). Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Eravacycline Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI). Current proprietary name Already available biosimilars / generics Proprietary name Xerava Manufacturer PAION Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise 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 Particularity ATMP No Submission date April 2025 Expected Registration December 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Rejected Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT06794541; NCT03696550 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Gezien lage resistentie en goede alternatieven wordt dit middel in Nederland niet tot zeer weinig ingezet. Expected cost per patient per year Cost References farmacotherapeutisch kompas Additional remarks De prijs voor één 100mg injectieflacon eravacycline (Xerava) is €125 (exclusief BTW). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks