🇪🇺 Basiliximab, Tacrolimus, MMF, Prednisolon in European Union

EMA authorised Basiliximab, Tacrolimus, MMF, Prednisolon on 9 October 1998

Marketing authorisation

EMA — authorised 9 October 1998

  • Application: EMEA/H/C/000207
  • Marketing authorisation holder: Novartis Europharm Limited
  • Local brand name: Simulect
  • Indication: Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
  • Status: approved

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Frequently asked questions

Is Basiliximab, Tacrolimus, MMF, Prednisolon approved in European Union?

Yes. EMA authorised it on 9 October 1998.

Who is the marketing authorisation holder for Basiliximab, Tacrolimus, MMF, Prednisolon in European Union?

Novartis Europharm Limited holds the EU marketing authorisation.