Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Myfenax   
Auth. number : EU/1/07/438
INN : Mycophenolate mofetil
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA06 - Mycophenolic acid
(See WHO ATC Index)
Indication: Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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 continues to be 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
25/02/2008 Centralised - Authorisation EMEA/H/C/884 (2008)767 of 21/02/2008
29/07/2008 Centralised - Variation EMEA/H/C/884/II/1 (2008)4101 of 25/07/2008
02/12/2008 Centralised - Variation EMEA/H/C/884/IB/2
Updated with Decision(2009)1454 of 26/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/884/II/3 (2009)1454 of 26/02/2009
23/04/2009 Corrigendum (2009)3138 of 21/04/2009
01/07/2009 Centralised - Variation EMEA/H/C/884/IA/5
15/07/2009 Centralised - Variation EMEA/H/C/884/IB/6
25/08/2009 Centralised - Variation EMEA/H/C/884/II/4 (2009)6629 of 21/08/2009
23/03/2010 Centralised - Variation EMEA/H/C/884/II/7 (2010)2045 of 23/03/2010
15/07/2010 Centralised - Variation EMEA/H/C/884/N/8
Updated with Decision(2011)3883 of 27/05/2011
22/09/2010 Centralised - Variation EMEA/H/C/884/IA/9/G
22/10/2010 Centralised - Variation EMEA/H/C/884/IA/11/G
Updated with Decision(2011)3883 of 27/05/2011
12/11/2010 Centralised - Variation EMEA/H/C/884/N/10
Updated with Decision(2011)3883 of 27/05/2011
15/02/2011 Centralised - Variation EMEA/H/C/884/IB/12
Updated with Decision(2011)3883 of 27/05/2011
31/05/2011 Centralised - Variation (2011)3883 of 27/05/2011
13/06/2012 Centralised - Variation EMEA/H/C/884/IAin/14/G
Updated with Decision(2012)4063 of 11/06/2012
13/06/2012 Centralised - Variation (2012)4063 of 11/06/2012
17/09/2012 Centralised - Variation EMEA/H/C/884/IB/16
Updated with Decision(2012)8592 of 19/11/2012
22/11/2012 Centralised - Renewal EMEA/H/C/884/R/15 (2012)8592 of 19/11/2012
30/10/2013 Centralised - Variation EMEA/H/C/884/IB/20