Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Myclausen   
Auth. number : EU/1/10/647
Active substance : 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: Myclausen 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: Herbert J. Passauer GmbH & Co. KG
Stubenrauchstrasse 33, D-14167 Berlin, Deutschland
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
11/10/2010 Centralised - Authorisation EMEA/H/C/1218 (2010)7081 of 07/10/2010
07/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/2
18/02/2011 Centralised - Variation EMEA/H/C/1218/IB/1
Updated with Decision(2011)6602 of 16/09/2011
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/8
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/1218/IA/4
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/9
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/10
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/7
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1218/IA/11
15/03/2011 Centralised - Variation EMEA/H/C/1218/IA/6
Updated with Decision(2011)6602 of 16/09/2011
15/03/2011 Centralised - Variation EMEA/H/C/1218/IA/5
Updated with Decision(2011)6602 of 16/09/2011
06/04/2011 Centralised - Notification EMEA/H/C/1218/N/12
Updated with Decision(2011)6602 of 16/09/2011
09/06/2011 Centralised - Notification EMEA/H/C/1218/N/13
Updated with Decision(2011)6602 of 16/09/2011
20/09/2011 Centralised - Variation EMEA/H/C/1218/X/3 (2011)6602 of 16/09/2011
25/10/2011 Centralised - Notification EMEA/H/C/1218/N/14
Updated with Decision(2012)4850 of 28/06/2012
19/12/2011 Centralised - Variation EMEA/H/C/1218/IB/15
Updated with Decision(2012)4850 of 28/06/2012
03/07/2012 Centralised - Variation (2012)4850 of 28/06/2012
14/09/2012 Centralised - Variation EMEA/H/C/1218/IB/17
Updated with Decision(2012)7878 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7878 of 29/10/2012
21/10/2013 Centralised - Variation EMEA/H/C/1218/IB/19
Updated with Decision(2014)8179 of 27/10/2014
30/10/2013 Centralised - Variation EMEA/H/C/1218/IB/20
Updated with Decision(2014)8179 of 27/10/2014
25/04/2014 Centralised - Notification EMEA/H/C/1218/N/21
Updated with Decision(2014)8179 of 27/10/2014
24/10/2014 Centralised - Variation EMEA/H/C/1218/IA/22/G
29/10/2014 Centralised - Yearly update (2014)8179 of 27/10/2014
29/01/2015 Centralised - Variation EMEA/H/C/1218/IB/28