Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Modigraf   
Auth. number : EU/1/09/523
INN : Tacrolimus
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AD - Calcineurin inhibitors
Chemical substance: L04AD02 - Tacrolimus
(See WHO ATC Index)
Indication: Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, 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
20/05/2009 Centralised - Authorisation EMEA/H/C/954 (2009)4050 of 15/05/2009
24/09/2009 Centralised - Variation EMEA/H/C/954/IA/1
09/12/2009 Centralised - Variation EMEA/H/C/954/N/2
Updated with Decision(2011)2856 of 18/04/2011
25/08/2010 Centralised - Variation EMEA/H/C/954/IA/3/G
Updated with Decision(2011)2856 of 18/04/2011
11/01/2011 Centralised - Variation EMEA/H/C/954/IB/4
12/04/2011 Centralised - Variation EMEA/H/C/954/IA/5/G
Updated with Decision(2011)5058 of 07/07/2011
21/04/2011 Centralised - Variation (2011)2856 of 18/04/2011
11/07/2011 Centralised - Variation (2011)5058 of 07/07/2011
29/08/2011 Centralised - Variation EMEA/H/C/954/WS/131 (2011)6148 of 24/08/2011
03/09/2012 Centralised - Variation EMEA/H/C/954/II/10/G (2012)6122 of 30/08/2012
11/01/2013 Centralised - Variation
Updated with Decision(2013)1009 of 18/02/2013
20/02/2013 Centralised - Variation EMEA/H/C/954/WS/305 (2013)1009 of 18/02/2013
24/10/2013 Centralised - Variation EMEA/H/C/954/WS/382/17/G
Updated with Decision(2014)1135 of 17/02/2014
19/02/2014 Centralised - Renewal EMEA/H/C/954/R/19 (2014)1135 of 17/02/2014