🇪🇺 Hydroxycarbamide in European Union

EMA authorised Hydroxycarbamide on 29 June 2007

Marketing authorisation

EMA — authorised 29 June 2007

  • Application: EMEA/H/C/000689
  • Marketing authorisation holder: Theravia
  • Local brand name: Siklos
  • Indication: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.
  • Status: approved

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Hydroxycarbamide in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Hydroxycarbamide approved in European Union?

Yes. EMA authorised it on 29 June 2007.

Who is the marketing authorisation holder for Hydroxycarbamide in European Union?

Theravia holds the EU marketing authorisation.