🇪🇺 Sirolimus Oral Tablet in European Union

EMA authorised Sirolimus Oral Tablet on 13 March 2001

Marketing authorisation

EMA — authorised 13 March 2001

  • Application: EMEA/H/C/000273
  • Marketing authorisation holder: Pfizer Europe MA EEIG
  • Local brand name: Rapamune
  • Indication: Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.
  • Status: approved

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Sirolimus Oral Tablet in other countries

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

Frequently asked questions

Is Sirolimus Oral Tablet approved in European Union?

Yes. EMA authorised it on 13 March 2001.

Who is the marketing authorisation holder for Sirolimus Oral Tablet in European Union?

Pfizer Europe MA EEIG holds the EU marketing authorisation.