Favourable opinion for reimbursement in “preterm or full-term neonates, infants, children and adolescents in need of intravenous nutrition to meet basal requirements for trace elements.”
Clinical Benefit
Substantial
The clinical benefit of PEDITRACE concentrate for solution for infusion (zinc chloride, copper chloride dihydrate, sodium selenite, manganese chloride tetrahydrate, potassium iodide) is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the qualitative and quantitative composition that complies with European recommendations in preterm neonates, but the possible risk of an excessive zinc and/or selenium intake in the other paediatric age groups,
the well-established use of trace elements in paediatric medicine,
the absence, however, of clinical data having assessed the efficacy and safety of this trace element combination, and of available use data for PEDITRACE despite this medicinal product being marketed in Sweden,
an already met medical need,
the Committee deems that PEDITRACE concentrate for solution for infusion (zinc chloride, copper chloride dihydrate, sodium selenite, manganese chloride tetrahydrate, potassium iodide) provides no clinical added value (CAV V) in the MA indication, in the context of an intravenous nutritional protocol to cover the basal requirements for trace elements in preterm or full-term neonates, infants, children and adolescents.
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