Glycopyrronium Medicine 04 June 2024 Extended indication Extension of indication to include treatment of children aged from 2 years and older for severe drooling Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Glycopyrronium Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication Extension of indication to include treatment of children aged from 2 years and older for severe drooling Current proprietary name Already available biosimilars / generics Proprietary name Sialanar Manufacturer Pacira Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2024 Expected Registration November 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice 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 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks