epoetin theta

This medicine is authorised for use in the European Union.


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 for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 04/05/2018

Authorisation details

Product details
Agency product number
Active substance
epoetin theta
International non-proprietary name (INN) or common name
epoetin theta
Therapeutic area (MeSH)
  • Kidney Failure, Chronic
  • Anemia
  • Cancer
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Teva GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Graf-Arco-Straße 3
D-89079 Ulm

Product information

23/03/2018 Biopoin - EMEA/H/C/001036 - IAIN/0043


  • 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

Other antianemic preparations

Therapeutic indication

Treatment of symptomatic anaemia associated with chronic renal failure in adult patients.

Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Assessment history

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