Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Biopoin   
Auth. number : EU/1/09/565
Active substance : 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: Teva 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
27/10/2009 Centralised - Authorisation EMEA/H/C/1036 (2009)8379 of 23/10/2009
17/03/2010 Centralised - Variation EMEA/H/C/1036/II/1 (2010)1833 of 15/03/2010
02/08/2010 Centralised - Variation EMEA/H/C/1036/IB/2/G
Updated with Decision(2011)884 of 08/02/2011
10/02/2011 Centralised - Variation (2011)884 of 08/02/2011
28/03/2011 Centralised - Notification EMEA/H/C/1036/N/3
Updated with Decision(2011)5846 of 05/08/2011
10/08/2011 Centralised - Variation EMEA/H/C/1036/II/4 (2011)5846 of 05/08/2011
17/10/2011 Centralised - Notification EMEA/H/C/1036/N/6
Updated with Decision(2012)7216 of 10/10/2012
02/03/2012 Centralised - Variation EMEA/H/C/1036/IAin/7
Updated with Decision(2012)7216 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7216 of 10/10/2012
20/12/2012 Centralised - Variation EMEA/H/C/1036/IB/11
Updated with Decision(2013)6806 of 09/10/2013
11/10/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1036/T/15 (2013)6806 of 09/10/2013
27/11/2013 Centralised - Variation EMEA/H/C/1036/IB/18
Updated with Decision(2014)6197 of 26/08/2014
28/08/2014 Centralised - Renewal EMEA/H/C/1036/R/20 (2014)6197 of 26/08/2014