Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Advagraf   
Auth. number : EU/1/07/387
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 kidney or liver allograft recipients.
Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult 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
25/04/2007 Centralised - Authorisation EMEA/H/C/712 (2007)1887 of 23/04/2007
30/07/2007 Centralised - Variation EMEA/H/C/712/IB/1
Updated with Decision(2008)394 of 25/01/2008
30/07/2007 Centralised - Variation EMEA/H/C/712/IB/2
Updated with Decision(2008)394 of 25/01/2008
29/01/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/712/T/3 (2008)394 of 25/01/2008
27/08/2008 Centralised - Variation EMEA/H/C/712/IA/6
Updated with Decision(2008)6486 of 28/10/2008
30/10/2008 Centralised - Variation EMEA/H/C/712/II/5, 7 (2008)6486 of 28/10/2008
18/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/712/IB/11
18/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/712/IB/12
19/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/712/IB/10
27/02/2009 Centralised - Variation EMEA/H/C/712/II/8 (2009)1388 of 25/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/712/II/9 (2009)2303 of 25/03/2009
29/04/2009 Centralised - Variation EMEA/H/C/712/X/4 (2009)3366 of 27/04/2009
04/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/712/IA/13
29/01/2010 Centralised - Notification EMEA/H/C/712/N/14
Updated with Decision(2011)2943 of 20/04/2011
12/07/2010 Corrigendum EMEA/H/C/712/X/4 (2009)3366 corr of 06/07/2010
23/08/2010 Centralised - Variation EMEA/H/C/712/IA/15/G
Updated with Decision(2011)2943 of 20/04/2011
20/09/2010 Centralised - Variation EMEA/H/C/712/IA/16/G
Updated with Decision(2011)2943 of 20/04/2011
17/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/712/IB/17
07/04/2011 Centralised - Variation EMEA/H/C/712/IA/18/G
Updated with Decision(2011)4846 of 29/06/2011
28/04/2011 Centralised - Variation (2011)2943 of 20/04/2011
05/07/2011 Centralised - Variation (2011)4846 of 29/06/2011
07/09/2011 Centralised - Variation EMEA/H/C/712/WS/131 (2011)6377 of 05/09/2011
04/11/2011 Centralised - Variation EMEA/H/C/712/II/20 (2011)7937 of 27/10/2011
24/11/2011 Centralised - Variation EMEA/H/C/712/II/22 (2011)8693 of 22/11/2011
17/04/2012 Centralised - Renewal EMEA/H/C/712/R/23 (2012)2545 of 13/04/2012
24/08/2012 Centralised - Variation EMEA/H/C/712/IB/28
Updated with Decision(2012)7904 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7904 of 29/10/2012
12/12/2012 Corrigendum
11/01/2013 Centralised - Variation EMEA/H/C/712/IA/34
Updated with Decision(2013)1010 of 18/02/2013
20/02/2013 Centralised - 2-Monthly update EMEA/H/C/712/WS/305/29 (2013)1010 of 18/02/2013
24/04/2013 Corrigendum (2009)3366 of 01/06/2010
24/10/2013 Centralised - Variation EMEA/H/C/712/WS/382
06/03/2014 Corrigendum (2013)1010 of 18/02/2013
06/03/2014 Corrigendum (2013)1010 of 18/02/2013
06/03/2014 Corrigendum (2013)1010 of 18/02/2013
06/03/2014 Corrigendum (2013)1010 of 18/02/2013