Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Epoetin alfa Hexal   
Auth. number : EU/1/07/411
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: Epoetin alfa HEXAL 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.
Epoetin alfa HEXAL 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.
Epoetin alfa HEXAL 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).
Epoetin alfa HEXAL 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: Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, 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
03/09/2007 Centralised - Authorisation EMEA/H/C/726 (2007)4102 of 28/08/2007
03/09/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/726 (2007)4103 of 28/08/2007
04/03/2008 Centralised - Variation EMEA/H/C/726/II/2 (2008)879 of 29/02/2008
23/05/2008 Centralised - Notification EMEA/H/C/726/N/5
Updated with Decision(2008)3590 of 08/07/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/II/3
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/II/4
10/07/2008 Centralised - Variation EMEA/H/C/726/II/1 (2008)3590 of 08/07/2008
17/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/IA/7
03/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/II/8
31/10/2008 Centralised - Variation EMEA/H/C/726/II/9 (2008)6530 of 29/10/2008
17/11/2008 Centralised - Variation EMEA/H/C/726/IA/11
Updated with Decision(2009)5693 of 10/07/2009
26/11/2008 Centralised - Variation EMEA/H/C/726/II/6 (2008)7459 of 21/11/2008
05/05/2009 Centralised - Notification EMEA/H/C/726/N/13
Updated with Decision(2009)5693 of 10/07/2009
07/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/II/12
14/07/2009 Centralised - Variation (2009)5693 of 10/07/2009
27/08/2009 Centralised - Variation EMEA/H/C/726/II/14 (2009)6665 of 25/08/2009
09/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/IA/16
05/10/2009 Centralised - Variation EMEA/H/C/726/X/10 (2009)7664 of 01/10/2009
19/11/2009 Centralised - Variation EMEA/H/C/726/IA/19
Updated with Decision(2009)10502 of 16/12/2009
21/12/2009 Centralised - Variation EMEA/H/C/726/II/15 (2009)10502 of 16/12/2009
25/01/2010 Centralised - Variation EMEA/H/C/726/II/18 (2010)413 of 20/01/2010
25/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/II/17
10/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/IB/20
03/08/2010 Centralised - Variation EMEA/H/C/726/IG/13/G
Updated with Decision(2011)1783 of 14/03/2011
20/08/2010 Centralised - Variation EMEA/H/C/726/WS/13 (2010)5847 of 18/08/2010
22/10/2010 Centralised - Variation EMEA/H/C/726/IA/21/G
Updated with Decision(2011)1783 of 14/03/2011
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/WS/78
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/WS/51
28/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/726/IA/50/G
17/03/2011 Centralised - Variation EMEA/H/C/726/WS/84 (2011)1783 of 14/03/2011
18/03/2011 Centralised - Variation EMEA/H/C/726/WS/84 (2011)1783 of 14/03/2011
21/06/2012 Centralised - Renewal EMEA/H/C/726/R/31 (2012)4268 of 18/06/2012
13/03/2013 Centralised - Variation EMEA/H/C/726/IG/287/G
Updated with Decision(2014)2041 of 21/03/2014
13/03/2013 Centralised - Variation EMEA/H/C/726/IG/281/G
Updated with Decision(2014)2041 of 21/03/2014
26/03/2014 Centralised - Yearly update (2014)2041 of 21/03/2014
04/08/2015 Centralised - 2-Monthly update EMEA/H/C/726/WS/764 (2015)5578 of 31/07/2015