Simulect

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basiliximab

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 18/05/2018

Authorisation details

Product details
Name
Simulect
Agency product number
EMEA/H/C/000207
Active substance
basiliximab
International non-proprietary name (INN) or common name
basiliximab
Therapeutic area (MeSH)
  • Graft Rejection
  • Kidney Transplantation
Anatomical therapeutic chemical (ATC) code
L04AC02
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
09/10/1998
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

12/04/2018 Simulect - EMEA/H/C/000207 - T/0094

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

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.

Assessment history

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