Silapo

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epoetin zeta

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

Overview

This is a summary of the European public assessment report (EPAR) for Silapo. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Silapo.

This EPAR was last updated on 15/11/2017

Authorisation details

Product details
Name
Silapo
Agency product number
EMEA/H/C/000760
Active substance
epoetin zeta
International non-proprietary name (INN) or common name
epoetin zeta
Therapeutic area (MeSH)
  • Anemia
  • Blood Transfusion, Autologous
  • Cancer
  • Kidney Failure, Chronic
Anatomical therapeutic chemical (ATC) code
B03XA01
Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Stada Arzneimittel AG
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
17/12/2007
Contact address
Stada R AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Product information

25/09/2017 Silapo - EMEA/H/C/000760 - IAIN/0048

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

ANTIANEMIC PREPARATIONS

Therapeutic indication

  • Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
    • treatment of anaemia associated with CRF in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4);
    • Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4);
  • treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre‑existing anaemia at the start of chemotherapy).
  • Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).

Assessment history

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