Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eporatio   
Auth. number : EU/1/09/573
INN : epoetin theta
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B03 - Antianemic preparations
Pharmacological subgroup: B03X - Other antianemic preparations
Chemical subgroup: B03XA - Other antianemic preparations
Chemical substance: B03XA01 - Erythropoietin
(See WHO ATC Index)
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.
Marketing Authorisation Holder: ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/11/2009 Centralised - Authorisation EMEA/H/C/1033 (2009)8563 of 29/10/2009
15/03/2010 Centralised - Variation EMEA/H/C/1033/II/1 (2010)1653 of 11/03/2010
02/08/2010 Centralised - Variation EMEA/H/C/1033/IB/2
Updated with Decision(2011)981 of 11/02/2011
01/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1033/IA/3
15/02/2011 Centralised - Variation (2011)981 of 11/02/2011
29/07/2011 Centralised - Variation EMEA/H/C/1033/II/4 (2011)5576 of 27/07/2011
18/10/2011 Centralised - Notification EMEA/H/C/1033/N/6
Updated with Decision(2013)9722 of 18/12/2013
20/12/2012 Centralised - Variation EMEA/H/C/1033/IB/10
Updated with Decision(2013)9722 of 18/12/2013
29/10/2013 Centralised - Notification EMEA/H/C/1033/N/14
Updated with Decision(2013)9722 of 18/12/2013
27/11/2013 Centralised - Variation EMEA/H/C/1033/IB/17
Updated with Decision(2013)9722 of 18/12/2013
20/12/2013 Centralised - Yearly update (2013)9722 of 18/12/2013
15/09/2014 Centralised - Renewal EMEA/H/C/1033/R/19 (2014)6512 of 11/09/2014