Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mircera   
Auth. number : EU/1/07/400
INN : methoxy polyethylene glycol-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: B03XA03 - Methoxy polyethylene glycol-epoetin beta
(See WHO ATC Index)
Indication: Treatment of symptomatic anaemia associated with chronic kidney disease (CKD).
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
24/07/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/739 (2007)3631 of 20/07/2007
25/07/2007 Centralised - Authorisation EMEA/H/C/739 (2007)3630 of 20/07/2007
16/01/2008 Corrigendum EMEA/H/C/739 (2008)865 corr of 11/01/2008
01/02/2008 Centralised - Variation EMEA/H/C/739/IB/4
25/02/2008 Centralised - Variation EMEA/H/C/739/II/3
07/03/2008 Centralised - Variation EMEA/H/C/739/II/2 (2008)951 of 05/03/2008
25/04/2008 Centralised - Variation EMEA/H/C/739/II/5 (2008)1700 of 23/04/2008
11/06/2008 Centralised - Variation EMEA/H/C/739/II/8
11/06/2008 Centralised - Variation EMEA/H/C/739/II/7
29/07/2008 Centralised - Variation EMEA/H/C/739/II/9
29/07/2008 Centralised - Variation EMEA/H/C/739/II/10
09/09/2008 Centralised - Variation EMEA/H/C/739/X/1 (2008)5014 of 05/09/2008
07/01/2009 Centralised - Variation EMEA/H/C/739/IA/14
08/01/2009 Centralised - Variation EMEA/H/C/739/IA/15
Updated with Decision(2009)2873 of 07/04/2009
23/01/2009 Centralised - Variation EMEA/H/C/739/N/11
Updated with Decision(2009)2873 of 07/04/2009
09/04/2009 Centralised - Variation EMEA/H/C/739/II/12, 13 (2009)2873 of 07/04/2009
30/07/2009 Centralised - Variation EMEA/H/C/739/II/18
30/07/2009 Centralised - Variation EMEA/H/C/739/II/17
13/10/2009 Centralised - Variation EMEA/H/C/739/IB/20
Updated with Decision(2010)1774 of 15/03/2010
13/10/2009 Centralised - Variation EMEA/H/C/739/IB/21
Updated with Decision(2010)1774 of 15/03/2010
14/10/2009 Centralised - Variation EMEA/H/C/739/IB/19
Updated with Decision(2010)1774 of 15/03/2010
18/01/2010 Centralised - Variation EMEA/H/C/739/IB/25
09/02/2010 Centralised - Variation EMEA/H/C/739/II/23
09/02/2010 Centralised - Variation EMEA/H/C/739/II/24
17/03/2010 Centralised - Variation (2010)1774 of 15/03/2010
04/05/2010 Centralised - Variation EMEA/H/C/739/II/26 (2010)2931 of 29/04/2010
08/06/2010 Centralised - Variation EMEA/H/C/739/II/22 (2010)3704 of 04/06/2010
27/07/2010 Centralised - Variation EMEA/H/C/739/IB/28
Updated with Decision(2010)6023 of 26/08/2010
31/08/2010 Centralised - Variation EMEA/H/C/739/II/27 (2010)6023 of 26/08/2010
31/08/2010 Centralised - Variation EMEA/H/C/739/IB/29
Updated with Decision(2010)7027 of 05/10/2010
07/10/2010 Centralised - Variation (2010)7027 of 05/10/2010
22/02/2011 Centralised - Variation EMEA/H/C/739/IB/30/G
Updated with Decision(2011)4462 of 17/06/2011
23/06/2011 Centralised - Variation EMEA/H/C/739/H/C/II/31 (2011)4462 of 17/06/2011
27/06/2011 Centralised - Variation EMEA/H/C/739/IB/33
Updated with Decision(2011)7672 of 20/10/2011
24/10/2011 Centralised - Variation EMEA/H/C/739/II/34, 35 (2011)7672 of 20/10/2011
17/05/2012 Centralised - Renewal EMEA/H/C/739/R/37 (2012)3317 of 15/05/2012
24/09/2012 Referral EMEA/H/C/739/A-20/39 (2012)6701 of 20/09/2012
19/12/2013 Centralised - Variation EMEA/H/C/739/IB/47
13/05/2014 Centralised - Variation EMEA/H/C/739/IAIN/48