Rapamune

RSS

sirolimus

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Rapamune and why it is authorised in the EU

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 13/09/2018

Authorisation details

Product details
Name
Rapamune
Agency product number
EMEA/H/C/000273
Active substance
Sirolimus
International non-proprietary name (INN) or common name
sirolimus
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AA10
Publication details
Marketing-authorisation holder
Pfizer Limited
Revision
37
Date of issue of marketing authorisation valid throughout the European Union
13/03/2001
Contact address
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

02/08/2018 Rapamune - EMEA/H/C/000273 - II/0164

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

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.

Assessment history

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