Oritavancin diphosphate

Extended indication	Extension of indication to include treatment of paediatric population, aged between 3 months and less than 18 years for acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Oritavancin diphosphate
Domain	Infectious diseases
Reason of inclusion	Indication extension
Main indication	Bacterial infections
Extended indication	Extension of indication to include treatment of paediatric population, aged between 3 months and less than 18 years for acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Proprietary name	Tenkasi
Manufacturer	Menarini
Route of administration	Intravenous
Therapeutical formulation	Intravenous drip
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	September 2022
Expected Registration	July 2023
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.