Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Binocrit   
Auth. number : EU/1/07/410
INN : epoetin alfa
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 paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4).
- Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4).

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).

Binocrit 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 (haemoglobin (Hb) 10-13 g/dl (6.2-8.1 mmol/l), 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).

Binocrit 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 or 6.2-8.1 mmol/l) who do not have an autologous predonation programme available and with an expected moderate blood loss of 900 to 1800 ml.

Good blood management practices should always be used in the perisurgical setting.
Marketing Authorisation Holder: Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich

  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
31/08/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/725 (2007)4114 of 28/08/2007
31/08/2007 Centralised - Authorisation EMEA/H/C/725 (2007)4113 of 28/08/2007
04/03/2008 Centralised - Variation EMEA/H/C/725/II/2 (2008)861 of 29/02/2008
06/05/2008 Centralised - Variation EMEA/H/C/725/II/3
23/05/2008 Centralised - Variation EMEA/H/C/725/N/5
Updated with Decision(2008)3592 of 08/07/2008
30/06/2008 Centralised - Variation EMEA/H/C/725/II/4
10/07/2008 Centralised - Variation EMEA/H/C/725/II/1 (2008)3592 of 08/07/2008
17/07/2008 Centralised - Variation EMEA/H/C/725/IA/7
03/10/2008 Centralised - Variation EMEA/H/C/725/II/8
31/10/2008 Centralised - Variation EMEA/H/C/725/II/9 (2008)6534 of 29/10/2008
19/11/2008 Centralised - Variation EMEA/H/C/725/IA/11
Updated with Decision(2009)5695 of 10/07/2009
25/11/2008 Centralised - Variation EMEA/H/C/725/II/6 (2008)7461 of 21/11/2008
05/05/2009 Centralised - Variation EMEA/H/C/725/N/13
Updated with Decision(2009)5695 of 10/07/2009
08/05/2009 Centralised - Variation EMEA/H/C/725/II/12
14/07/2009 Centralised - Variation (2009)5695 of 10/07/2009
27/08/2009 Centralised - Variation EMEA/H/C/725/II/14 (2009)6666 of 25/08/2009
10/09/2009 Centralised - Variation EMEA/H/C/725/IA/16
05/10/2009 Centralised - Variation EMEA/H/C/725/X/10 (2009)7648 of 01/10/2009
19/11/2009 Centralised - Variation EMEA/H/C/725/IA/19
Updated with Decision(2009)10501 of 16/12/2009
18/12/2009 Centralised - Variation EMEA/H/C/725/II/15 (2009)10501 of 16/12/2009
22/01/2010 Centralised - Variation EMEA/H/C/725/II/18 (2010)396 of 20/01/2010
25/03/2010 Centralised - Variation EMEA/H/C/725/II/17
10/05/2010 Centralised - Variation EMEA/H/C/725/IB/20
03/08/2010 Centralised - Variation EMEA/H/C/725/IG/13/G
Updated with Decision(2011)1780 of 14/03/2011
20/08/2010 Centralised - Variation EMEA/H/C/725/WS/13 (2010)5846 of 18/08/2010
22/10/2010 Centralised - Variation EMEA/H/C/725/IA/21/G
Updated with Decision(2011)1780 of 14/03/2011
21/01/2011 Centralised - Variation EMEA/H/C/725/WS/51
21/01/2011 Centralised - Variation EMEA/H/C/725/WS/78
28/02/2011 Centralised - Variation EMEA/H/C/725/IG/50
16/03/2011 Centralised - Variation EMEA/H/C/725/WS/84 (2011)1781 of 14/03/2011
17/03/2011 Centralised - Variation EMEA/H/C/725/IB/WS/84 (2011)1780 of 14/03/2011
31/03/2011 Centralised - Variation EMEA/H/C/725/N/22
Updated with Decision(2012)4267 of 18/06/2012
12/12/2011 Centralised - Variation EMEA/H/C/725/N/23
Updated with Decision(2012)4267 of 18/06/2012
21/06/2012 Centralised - Renewal EMEA/H/C/725/R/33 (2012)4267 of 18/06/2012
13/03/2013 Centralised - Variation EMEA/H/C/725/IG/281/G
Updated with Decision(2014)2040 of 21/03/2014
13/03/2013 Centralised - Variation EMEA/H/C/725/IG/287/G
Updated with Decision(2014)2040 of 21/03/2014
26/03/2014 Centralised - Variation (2014)2040 of 21/03/2014