Botulinum A toxin Medicine 13 December 2018 Extended indication Treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Botulinum A toxin Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases Extended indication Treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Evolus Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Submission date August 2017 Expected Registration February 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement 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