Is Epoetin theta authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Epoetin theta: Biopoin, Eporatio.

Is Epoetin theta on the WHO Model List of Essential Medicines?

Yes — 10.1. Antianaemia medicines (complementary list): Therapeutic equivalent to erythropoiesis-stimulating agents for Anaemia due to chronic disease.

Are there safety signals or safety updates for Epoetin theta?

EMA PRAC: 2 entries (latest 2017-07-06).

Active substance

Epoetin theta

EMA 3
WHO EML 1
Safety 2

Open in the medicines table

EMA European Union — centrally authorised medicines

Biopoin Teva GmbH · Authorised · authorised 23 Oct 2009 · ATC B03XA01

Therapeutic indication (EMA)

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.

Eporatio Ratiopharm GmbH · Authorised · authorised 29 Oct 2009 · ATC B03XA01

Therapeutic indication (EMA)

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.

Ratioepo Ratiopharm GmbH · Application withdrawn · ATC B03XA01

Therapeutic indication (EMA)

Treatment of symptomatic anaemia associated with chronic renal failure in adult patients and treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy

WHO WHO Model List of Essential Medicines (2025)

10.1. Antianaemia medicines · complementary
Therapeutic equivalent to erythropoiesis-stimulating agents for Anaemia due to chronic disease

Safety signals and safety-related labeling changes

EMA PRAC 6 Jul 2017 PRAC signal: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Feb 2017 PRAC signal: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Action for MAH: update of the product information: No

All safety entries for epoetin theta →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.