Extended indication Doxycycline in combination with standard of care for preventive treatment of post abdominal colorectal Surgical site infection in adults and elderly u
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Doxycycline
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Doxycycline in combination with standard of care for preventive treatment of post abdominal colorectal Surgical site infection in adults and elderly undergoing surgeries with incisions greater than 20 cm.
Manufacturer Advanz
Mechanism of action Antibiotic
Route of administration Local
Therapeutical formulation Powder for topical use
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date June 2026
Expected Registration July 2027
Registration phase Clinical trials

Therapeutic value

Therapeutic value No estimate possible yet

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

Substantiation De resultaten van de SHIELD II trial moeten worden afgewacht totdat er een inschatting gemaakt kan worden van de therapeutische waarde.
References NCT04411199 (SHIELD II)

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

References Expertopinie
Additional remarks Het volume dat in aanmerking zal komen voor dit middel is afhankelijk van het aantal colorectale operatie met een incisie groter dan 20 cm.

Expected cost per patient per year

Cost < 100.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

References medicijnkosten.nl; IHSI
Additional remarks Betreft een nieuwe toedieningsvorm. De kosten per 100mg tablet zijn €0,58. Verwachte jaarlijkse kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten voor dit geneesmiddel in Nederland.

Potential total cost per year

Off label use

Indication extension

Other information