JUNIMIN (copper, iodine, manganese, selenium, zinc), trace elements
NUTRITION - New medicinal product
Opinions on drugs -
Posted on
Oct 18 2017
Reason for request
Inclusion
No clinical benefit for intravenous coverage of trace element needs in premature or full-term newborns, infants and children.
- JUNIMIN has marketing authorisation in the context of an intravenous nutritional protocol to cover basic trace element needs in premature or full-term newborns, infants and children.
- Its qualitative and quantitative composition, overall compliant with international standards, responds to a medical need that is only partially covered by the medicinal product.
- JUNIMIN is intended to replace SOLUTION INJECTABLE D’OLIGOELEMENTS POUR ENFANTS ET NOURRISSONS AGUETTANT [Aguettant Trace Elements Solution for Injection for Newborns and Children], the composition of which is no longer compliant.
- This is a first-line treatment.
Clinical Benefit
Substantial |
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Clinical Added Value
no clinical added value |
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