Alpha-1-antitrypsin Medicine 09 January 2018 Extended indication Alpha-1 antitrypsin deficiency (AATD); inhaled therapy for emphysema. Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Alpha-1-antitrypsin Domain Lung diseases Reason of inclusion Main indication Lung other Extended indication Alpha-1 antitrypsin deficiency (AATD); inhaled therapy for emphysema. Current proprietary name Already available biosimilars / generics Proprietary name Glassia Manufacturer Kamada Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Kamada heeft de registratieaanvraag teruggetrokken in juni 2017. De EMA heeft aangegeven dat de huidige aanvraag niet voldoende onderbouwd is voor toelating. Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Unknown Registration phase Unknown 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