Methotrexaat Medicine 04 June 2026 Extended indication Methotrexate monotherapy for induction, consolidation, maintenance treatment of primary vitreoretinal Lymphoma in adults over 21 years of age and elderly. Therapeutic value Total cost Registration phase Clinical trials Product Active substance Methotrexaat Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Methotrexate monotherapy for induction, consolidation, maintenance treatment of primary vitreoretinal Lymphoma in adults over 21 years of age and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Aldeyra Portfolio holder Mechanism of action Route of administration Intravitreal Therapeutical formulation Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP Submission date March 2027 Expected Registration April 2028 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks