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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Myfenax
|
| Auth. number : | EU/1/07/438 |
| INN : | Mycophenolate mofetil |
| ATC: | L - Antineoplastic and immunomodulating agents L04 - Immunosuppressive agents L04A - Immunosuppressive agents L04AA - Selective immunosuppressive agents 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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 |