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Pharmaceuticals - Community Register
Community register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Binocrit
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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 procedures |
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 |