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CHMP recommends a change to the indication of Xromi (hydroxycarbamide) to include prevention of sickle cell disease complications.- Nova Laboratories.

Read time: 1 mins
Published: 25th Feb 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xromi.

 

The marketing authorisation holder for this medicinal product is Nova Laboratories Ireland Limited. The CHMP adopted an extension to the existing indication to include prevention of sickle cell disease complications in infants from 9 months of age.

Condition: Sickle Cell Disease
Type: drug
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