Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NeoRecormon   
Auth. number : EU/1/97/031
INN : Epoetin beta
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: B03XA - Other antianemic preparations
(See WHO ATC Index)
Indication: - Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients.- Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy.- Increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving 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).
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

  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
17/07/1997 Centralised - Authorisation EMEA/H/C/116 (97)2181 of 16/07/1997
03/04/1998 Centralised - Authorisation EMEA/H/C/116/X/6 (1998)835 of 02/04/1998
05/10/1998 Centralised - Variation EMEA/H/C/116/I/3 (1998)2989 of 01/10/1998
13/11/1998 Centralised - Variation EMEA/H/C/116/II/4 (1998)3497 of 11/11/1998
13/05/1999 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/116/T/7 (1999)1283 of 07/05/1999
09/07/1999 Centralised - Variation EMEA/H/C/116/I/8 (1999)1851 of 01/07/1999
14/02/2000 Centralised - Authorisation EMEA/H/C/116/X/11, 12, 13 (2000)312 of 10/02/2000
14/02/2000 Centralised - Variation EMEA/H/C/116/II/10 (2000)311 of 10/02/2000
21/03/2001 Centralised - Variation EMEA/H/C/116/II/14 (2001)615 of 20/03/2001
01/06/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/16
02/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/17
06/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/18
19/09/2001 Centralised - Variation EMEA/H/C/116/II/15 (2001)2201 of 17/09/2001
16/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/19
27/08/2002 Centralised - Renewal EMEA/H/C/116/R/22 (2002)1470 of 22/08/2002
05/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/24
05/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/27
08/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/28
05/12/2002 Centralised - Variation EMEA/H/C/116/II/23 (2002)4919 of 03/12/2002
27/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/I/29
19/03/2003 Centralised - Variation EMEA/H/C/116/II/26 (2003)856 of 17/03/2003
30/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/30
26/02/2004 Centralised - Variation EMEA/H/C/116/X/31 (2004)626 of 23/02/2004
11/08/2004 Centralised - Notification EMEA/H/C/116/N/33
Updated with Decision(2005)2774 of 13/07/2005
22/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/34
15/12/2004 Centralised - Variation EMEA/H/C/116/IA/36
Updated with Decision(2005)2774 of 13/07/2005
25/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/35
27/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/38
20/05/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/IB/39
15/07/2005 Centralised - Variation EMEA/H/C/116/II/37 (2005)2774 of 13/07/2005
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/40
26/09/2005 Centralised - Variation EMEA/H/C/116/IA/45
Updated with Decision(2005)4532 of 17/11/2005
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/41, 42, 43
21/11/2005 Centralised - Variation EMEA/H/C/116/II/44 (2005)4532 of 17/11/2005
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/46
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/47
05/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/48
09/01/2007 Centralised - Variation EMEA/H/C/116/II/49 (2007)28 of 04/01/2007
17/04/2007 Centralised - Notification EMEA/H/C/116/N/51
Updated with Decision(2007)3180 of 25/06/2007
27/06/2007 Centralised - Renewal EMEA/H/C/116/R/50 (2007)3180 of 25/06/2007
02/10/2007 Centralised - Variation EMEA/H/C/116/IA/53
Updated with Decision(2008)815 of 26/02/2008
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/52
28/02/2008 Centralised - Variation EMEA/H/C/116/II/54 (2008)815 of 26/02/2008
27/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/IB/55
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/56
27/10/2008 Centralised - Variation EMEA/H/C/116/II/57 (2008)6308 of 23/10/2008
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/58
04/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/59
07/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/60
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/61
24/11/2009 Centralised - Variation EMEA/H/C/116/II/62 (2009)9335 of 20/11/2009
22/01/2010 Centralised - Variation EMEA/H/C/116/II/63 (2010)398 of 20/01/2010
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/65
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/116/II/64
04/05/2010 Centralised - Variation EMEA/H/C/116/II/66 (2010)2935 of 29/04/2010
21/03/2011 Centralised - Variation EMEA/H/C/116/IB/67/G
Updated with Decision(2011)7250 of 06/10/2011
31/05/2011 Centralised - Variation EMEA/H/C/116/IB/69
Updated with Decision(2011)7250 of 06/10/2011
09/09/2011 Centralised - Variation EMEA/H/C/116/IA/71
Updated with Decision(2011)7250 of 06/10/2011
10/10/2011 Centralised - Variation (2011)7250 of 06/10/2011
25/04/2012 Centralised - Notification EMEA/H/C/116/N/73
29/10/2013 Centralised - Notification EMEA/H/C/116/N/81