Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Binocrit   
Auth. number : EU/1/07/410
Active substance : 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: Binocrit is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
- in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis.
- in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients.
Binocrit is indicated in adults 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) for the treatment of anaemia and reduction of transfusion requirements.
Binocrit is indicated in adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dl [6.2 to 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 is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl or 6.2 to 8.1 mmol/l) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml).
Marketing Authorisation Holder: Sandoz GmbH
Biochemiestrasse 10, 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 EMEA/H/C/725 (2007)4113 of 28/08/2007
31/08/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/725 (2007)4114 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 (no change in Commission Decision) EMEA/H/C/725/II/3
23/05/2008 Centralised - Notification EMEA/H/C/725/N/5
Updated with Decision(2008)3592 of 08/07/2008
30/06/2008 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/725/IA/7
03/10/2008 Centralised - Variation (no change in Commission Decision) 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 - Notification EMEA/H/C/725/N/13
Updated with Decision(2009)5695 of 10/07/2009
08/05/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/725/II/17
10/05/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/725/WS/51
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/725/WS/78
28/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/725/IG/50
16/03/2011 Centralised - Variation - Decision addressed to Member States 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 - Notification EMEA/H/C/725/N/22
Updated with Decision(2012)4267 of 18/06/2012
20/04/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/725/IG/63
12/12/2011 Centralised - Notification 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
17/07/2013 Centralised - Variation EMEA/H/C/725/IB/41
Updated with Decision(2014)2040 of 21/03/2014
26/03/2014 Centralised - Yearly update (2014)2040 of 21/03/2014
04/08/2015 Centralised - 2-Monthly update EMEA/H/C/725/WS/764 (2015)5577 of 31/07/2015
04/04/2016 Centralised - 2-Monthly update EMEA/H/C/725/WS/877 (2016)2017 of 31/03/2016
13/10/2016 Centralised - Variation EMEA/H/C/725/WS/1032
Updated with Decision(2017)6145 of 07/09/2017
16/05/2017 Corrigendum (2016)2017 of 31/03/2016
11/09/2017 Centralised - Yearly update (2017)6145 of 07/09/2017
04/10/2017 Centralised - Variation EMEA/H/C/725/IG/847
16/11/2017 Corrigendum (2014)2040 of 21/03/2014