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FERROSTRANE INFANTS (sodium feredetate) - Iron-deficiency anaemia
Opinions on drugs -
Posted on
Apr 02 2025
Reason for request
First listing
Summary of opinion
Favourable opinion for reimbursement “in infants in the:
- curative treatment of iron-deficiency anaemia,
- prophylaxis of iron deficiency in preterm infants, twins or infants born to mothers with an iron deficiency, when an adequate dietary iron intake cannot be guaranteed”.
No clinical added value of the new form compared to the form already available.
Clinical Benefit
| Substantial |
The Committee considers that the clinical benefit of FERROSTRANE INFANTS 6.8 mg/mL (sodium feredetate) syrup is substantial in the MA indications. |
Clinical Added Value
| no clinical added value |
This medicinal product is a range supplement that does not provide any clinical added value (CAV V) compared to the form already listed. |
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