Biopoin

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epoetin theta

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

This EPAR was last updated on 11/01/2022

Authorisation details

Product details
Name
Biopoin
Agency product number
EMEA/H/C/001036
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
B03XA01
Publication details
Marketing-authorisation holder
Teva GmbH
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
23/10/2009
Contact address

Graf-Arco-Straße 3
D-89079 Ulm
Germany

Product information

05/01/2022 Biopoin - EMEA/H/C/001036 - N/0051

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

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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