Reason for request

Extension of indication and inclusion

Moderate clinical added value in the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapies in children and adolescents aged ≥ 6 months to 17 years.

 

  •  EMEND has marketing authorisation in the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapies in children aged ≥ 6 months.
  • The addition of EMEND to ondansetron, with or without dexamethasone, provides a better complete response (no vomiting or nausea and no use of rescue medication) during the delayed phase of the first cycle of highly or moderately emetogenic chemotherapy.
  • Its efficacy and safety, in combination with ondansetron and dexamethasone, in the paediatric population are overall comparable to those known in adults.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

moderate

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Therapeutic use

-

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