Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Abseamed   
Auth. number : EU/1/07/412
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).

Abseamed 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).

Abseamed 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: Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, D-58638 Iserlohn, 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
31/08/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/727 (2007)4115 of 28/08/2007
31/08/2007 Centralised - Authorisation EMEA/H/C/727 (2007)4116 of 28/08/2007
28/02/2008 Centralised - Variation EMEA/H/C/727/II/2 (2008)814 of 26/02/2008
23/05/2008 Centralised - Variation EMEA/H/C/727/N/5
Updated with Decision(2008)3367 of 27/06/2008
05/06/2008 Centralised - Variation EMEA/H/C/727/II/3
30/06/2008 Centralised - Variation EMEA/H/C/727/II/4
01/07/2008 Centralised - Variation EMEA/H/C/727/II/1 (2008)3367 of 27/06/2008
17/07/2008 Centralised - Variation EMEA/H/C/727/IA/7
02/10/2008 Centralised - Variation EMEA/H/C/727/II/8
24/10/2008 Centralised - Variation EMEA/H/C/727/II/9 (2008)6285 of 22/10/2008
17/11/2008 Centralised - Variation EMEA/H/C/727/IA/10
Updated with Decision(2009)5759 of 14/07/2009
25/11/2008 Centralised - Variation EMEA/H/C/727/II/6 (2008)7460 of 21/11/2008
29/04/2009 Centralised - Variation EMEA/H/C/727/II/11
05/05/2009 Centralised - Variation EMEA/H/C/727/N/12
Updated with Decision(2009)5759 of 14/07/2009
16/07/2009 Centralised - Variation (2009)5759 of 14/07/2009
01/09/2009 Centralised - Variation EMEA/H/C/727/II/13 (2009)6722 of 28/08/2009
10/09/2009 Centralised - Variation EMEA/H/C/727/IA/16
19/11/2009 Centralised - Variation EMEA/H/C/727/IA/19
Updated with Decision(2009)10330 of 11/12/2009
01/12/2009 Centralised - Variation EMEA/H/C/727/X/14 (2009)9594 of 26/11/2009
15/12/2009 Centralised - Variation EMEA/H/C/727/II/15 (2009)10330 of 11/12/2009
22/01/2010 Centralised - Variation EMEA/H/C/727/II/18 (2010)369 of 20/01/2010
25/03/2010 Centralised - Variation EMEA/H/C/727/II/17
12/05/2010 Centralised - Variation EMEA/H/C/727/IB/20
03/08/2010 Centralised - Variation EMEA/H/C/727/IA/21
Updated with Decision(2011)1721 of 10/03/2011
02/09/2010 Centralised - Variation EMEA/H/C/727/WS/13 (2010)6099 of 31/08/2010
10/11/2010 Centralised - Variation EMEA/H/C/727/IA/22/G
Updated with Decision(2011)1721 of 10/03/2011
25/01/2011 Centralised - Variation EMEA/H/C/727/WS/51/NC
27/01/2011 Centralised - Variation EMEA/H/C/727/WS/78
01/03/2011 Centralised - Variation EMEA/H/C/727/IG/50
11/03/2011 Centralised - Variation EMEA/H/C/727/WS/84 (2011)1722 of 10/03/2011
14/03/2011 Centralised - Variation EMEA/H/C/727/WS/84 (2011)1721 of 10/03/2011
19/06/2012 Centralised - Renewal EMEA/H/C/727/R/30 (2012)4206 of 15/06/2012
15/01/2013 Centralised - Variation EMEA/H/C/727/N/35
Updated with Decision(2014)2049 of 21/03/2014
13/03/2013 Centralised - Variation EMEA/H/C/727/IG/287/G
Updated with Decision(2014)2049 of 21/03/2014
13/03/2013 Centralised - Variation EMEA/H/C/727/IG/281
Updated with Decision(2014)2049 of 21/03/2014
17/07/2013 Centralised - Variation EMEA/H/C/727/IB/39
Updated with Decision(2014)2049 of 21/03/2014
26/03/2014 Centralised - Variation (2014)2049 of 21/03/2014