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Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mycophenolate mofetil Teva   
Auth. number : EU/1/07/439
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: Mycophenolate mofetil Teva 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 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
25/02/2008 Centralised - Authorisation EMEA/H/C/882 (2008)765 of 21/02/2008
29/07/2008 Centralised - Variation EMEA/H/C/882/II/1 (2008)4102 of 25/07/2008
03/12/2008 Centralised - Variation EMEA/H/C/882/IB/2
Updated with Decision(2009)1456 of 26/02/2009
02/03/2009 Centralised - Variation EMEA/H/C/882/II/3 (2009)1456 of 26/02/2009
23/04/2009 Corrigendum EMEA/H/C/882 (2009)3139 corr of 21/04/2009
01/07/2009 Centralised - Variation EMEA/H/C/882/IA/5
15/07/2009 Centralised - Variation EMEA/H/C/882/IB/6
25/08/2009 Centralised - Variation EMEA/H/C/882/II/4 (2009)6632 of 21/08/2009
25/03/2010 Centralised - Variation EMEA/H/C/882/II/7 (2010)2044 of 23/03/2010
15/07/2010 Centralised - Variation EMEA/H/C/882/N/8
Updated with Decision(2011)3884 of 27/05/2011
22/09/2010 Centralised - Variation EMEA/H/C/882/IA/9/G
22/10/2010 Centralised - Variation EMEA/H/C/882/IA/11/G
Updated with Decision(2011)3884 of 27/05/2011
12/11/2010 Centralised - Variation EMEA/H/C/882/N/10
Updated with Decision(2011)3884 of 27/05/2011
15/02/2011 Centralised - Variation EMEA/H/C/882/IB/12
Updated with Decision(2011)3884 of 27/05/2011
31/05/2011 Centralised - Variation (2011)3884 of 27/05/2011
13/06/2012 Centralised - Variation (2012)4064 of 11/06/2012
13/06/2012 Centralised - Variation EMEA/H/C/882/IA/14
Updated with Decision(2012)4064 of 11/06/2012
17/09/2012 Centralised - Variation EMEA/H/C/882/IB/16
Updated with Decision(2012)8591 of 19/11/2012
22/11/2012 Centralised - Renewal EMEA/H/C/882/R/15 (2012)8591 of 19/11/2012
30/10/2013 Centralised - Variation EMEA/H/C/882/IB/20