This medicine is authorised for use in the European Union.


Rapamune is a medicine used to prevent the body from rejecting a newly transplanted kidney. It is used in adults who are at a low to moderate risk of rejection. It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months. Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped.

Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function. S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children.

Rapamune contains the active substance sirolimus.

This EPAR was last updated on 25/07/2022

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Boulevard de la Plaine 17
1050 Bruxelles

Product information

22/07/2022 Rapamune - EMEA/H/C/000273 - IB/0189

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic 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.

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