Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Silapo   
Auth. number : EU/1/07/432
INN : epoetin zeta
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 anaemia and symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients.
Marketing Authorisation Holder: STADA Arzneimittel AG
Stadastrasse 2-18, D-61118 Bad Vilbel, 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
20/12/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/760 (2007)6752 of 18/12/2007
20/12/2007 Centralised - Authorisation EMEA/H/C/760 (2007)6753 of 18/12/2007
24/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IA/3
20/05/2008 Centralised - Variation EMEA/H/C/760/IB/6
Updated with Decision(2008)3966 of 22/07/2008
20/05/2008 Centralised - Variation EMEA/H/C/760/IB/5
Updated with Decision(2008)3966 of 22/07/2008
20/05/2008 Centralised - Variation EMEA/H/C/760/IB/4
Updated with Decision(2008)3966 of 22/07/2008
18/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IA/7
24/07/2008 Centralised - Variation EMEA/H/C/760/II/2 (2008)3966 of 22/07/2008
31/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/8
06/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/9
08/08/2008 Centralised - Variation EMEA/H/C/760/IB/10
Updated with Decision(2008)7503 of 24/11/2008
15/08/2008 Centralised - Variation EMEA/H/C/760/II/1 (2008)4532 of 13/08/2008
03/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/II/11
26/11/2008 Centralised - Variation EMEA/H/C/760/II/12 (2008)7503 of 24/11/2008
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/II/13
18/12/2009 Centralised - Variation EMEA/H/C/760/II/15 (2009)10503 of 16/12/2009
24/03/2010 Centralised - Variation EMEA/H/C/760/IB/16
Updated with Decision(2010)7266 of 15/10/2010
09/04/2010 Centralised - Variation EMEA/H/C/760/II/14 (2010)2327 of 06/04/2010
05/07/2010 Centralised - Decision addressed to Member States EMEA/H/C/760/II/14 (2010)4674 of 01/07/2010
02/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/19
02/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/17
02/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/18
19/10/2010 Centralised - Variation (2010)7266 of 15/10/2010
17/01/2011 Centralised - Variation EMEA/H/C/760/IB/22
Updated with Decision(2011)5832 of 05/08/2011
18/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/23
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/IB/21
18/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/760/II/20
26/05/2011 Centralised - Variation EMEA/H/C/760/IB/24
Updated with Decision(2011)5832 of 05/08/2011
10/08/2011 Centralised - Variation (2011)5832 of 05/08/2011
30/07/2012 Centralised - Renewal EMEA/H/C/760/R/26 (2012)5475 of 26/07/2012
13/10/2014 Centralised - Variation EMEA/H/C/760/IA/33