Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Retacrit   
Auth. number : EU/1/07/431
Active substance : 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 symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
    • Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis.
    • Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
  • Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
  • Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
    Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).
Marketing Authorisation Holder: Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
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 EMEA/H/C/872 (2007)6737 of 18/12/2007
20/12/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/872 (2007)6736 of 18/12/2007
18/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/2
12/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/3, 4
15/08/2008 Centralised - Variation EMEA/H/C/872/IB/5
Updated with Decision(2008)7462 of 21/11/2008
15/08/2008 Centralised - Variation EMEA/H/C/872/II/1 (2008)4536 of 13/08/2008
19/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/13
19/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/14
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/12
Updated with Decision(2008)7462 of 21/11/2008
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/11
Updated with Decision(2008)7462 of 21/11/2008
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/10
Updated with Decision(2008)7462 of 21/11/2008
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/9
Updated with Decision(2008)7462 of 21/11/2008
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/8
Updated with Decision(2008)7462 of 21/11/2008
05/09/2008 Centralised - Variation EMEA/H/C/872/IB/7
Updated with Decision(2008)7462 of 21/11/2008
03/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/II/6
06/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/17
06/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/18
25/11/2008 Centralised - Variation EMEA/H/C/872/II/15 (2008)7462 of 21/11/2008
12/01/2009 Centralised - Variation EMEA/H/C/872/II/16 (2009)50 of 07/01/2009
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/II/19
21/10/2009 Centralised - Variation EMEA/H/C/872/IA/21
Updated with Decision(2009)10777 of 23/12/2009
11/12/2009 Centralised - Notification EMEA/H/C/872/N/23
Updated with Decision(2010)2326 of 06/04/2010
31/12/2009 Centralised - Variation EMEA/H/C/872/II/22 (2009)10777 of 23/12/2009
24/03/2010 Centralised - Variation EMEA/H/C/872/IB/24
Updated with Decision(2010)7124 of 11/10/2010
14/04/2010 Centralised - Variation EMEA/H/C/872/II/20 (2010)2326 of 06/04/2010
19/04/2010 Centralised - Variation (refusal) EMEA/H/C/872/IA/25
09/07/2010 Centralised - Decision addressed to Member States EMEA/H/C/872/II/20 (2010)4682 of 01/07/2010
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/26
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/28
10/09/2010 Centralised - Variation EMEA/H/C/872/IA/29
Updated with Decision(2010)7124 of 11/10/2010
10/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/27
13/10/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/872/T/30 (2010)7124 of 11/10/2010
17/01/2011 Centralised - Variation EMEA/H/C/872/IB/33
Updated with Decision(2011)5527 of 26/07/2011
20/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/32
20/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IB/34
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/IA/35
18/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/872/II/31
27/05/2011 Centralised - Variation EMEA/H/C/872/IB/37
Updated with Decision(2011)5527 of 26/07/2011
28/07/2011 Centralised - Variation EMEA/H/C/872/II/36 (2011)5527 of 26/07/2011
19/11/2012 Centralised - Renewal EMEA/H/C/872/R/41 (2012)8481 of 15/11/2012
30/08/2013 Centralised - Variation EMEA/H/C/872/IAin/50
Updated with Decision(2014)6027 of 19/08/2014
21/08/2014 Centralised - 2-Monthly update EMEA/H/C/872/IB/55 (2014)6027 of 19/08/2014
08/01/2015 Centralised - Variation EMEA/H/C/872/IB/58/G
Updated with Decision(2015)5848 of 12/08/2015
15/04/2015 Centralised - Variation EMEA/H/C/872/IA/60/G
Updated with Decision(2015)5848 of 12/08/2015
12/06/2015 Centralised - Variation EMEA/H/C/872/IA/63
Updated with Decision(2015)5848 of 12/08/2015
14/08/2015 Centralised - 2-Monthly update EMEA/H/C/872/IB/65 (2015)5848 of 12/08/2015