Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Mepact   
Auth. number : EU/1/08/502
Active substance : mifamurtide
Orphan market exclusivity for "Treatment of osteosarcoma" (based on designation EU/3/04/206) started on 23/03/2009
   10 years of market exclusivity
   This orphan market exclusivity will expire on 23/03/2019
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L03 - Immunomodulating agents
Pharmacological subgroup: L03A - Immunostimulating agents
Chemical subgroup: L03AX - Other immunostimulating agents
Chemical substance: L03AX15 - Mifamurtide
(See WHO ATC Index)
Indication: MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis
Marketing Authorisation Holder: Takeda France SAS
Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France
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
23/03/2009 Centralised - Authorisation EMEA/H/C/802 (2009)1707 of 06/03/2009
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/3
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/1
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/4
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/2
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/6
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/5
19/01/2010 Centralised - Variation EMEA/H/C/802/IA/7
Updated with Decision(2010)5644 of 06/08/2010
31/03/2010 Centralised - Variation EMEA/H/C/802/IA/9
Updated with Decision(2010)5644 of 06/08/2010
26/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IB/11
27/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/12
29/07/2010 Centralised - Variation EMEA/H/C/802/IA/10/G
Updated with Decision(2010)6902 of 30/09/2010
13/08/2010 Centralised - Variation (2010)5644 of 06/08/2010
25/08/2010 Centralised - Variation EMEA/H/C/802/IA/14/G
Updated with Decision(2010)6902 of 30/09/2010
06/10/2010 Centralised - Variation (2010)6902 of 30/09/2010
15/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IA/13/G
31/01/2011 Centralised - Variation EMEA/H/C/802/IB/15
Updated with Decision(2011)6164 of 24/08/2011
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/802/IB/16
21/07/2011 Centralised - Variation (refusal) EMEA/H/C/802/IA/18
30/08/2011 Centralised - Variation (2011)6164 of 24/08/2011
01/06/2012 Referral EMEA/H/C/802/A-20/22 (2012)3588 of 25/05/2012
27/08/2012 Centralised - Variation EMEA/H/C/802/II/24 (2012)6024 of 23/08/2012
26/09/2012 Corrigendum (2012)6853 of 24/09/2012
17/01/2013 Centralised - Variation EMEA/H/C/802/II/25
Updated with Decision(2013)5789 of 05/09/2013
21/03/2013 Centralised - Variation EMEA/H/C/802/II/26
Updated with Decision(2013)5789 of 05/09/2013
10/06/2013 Centralised - Variation EMEA/H/C/802/IAin/33
Updated with Decision(2013)5789 of 05/09/2013
09/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/802/T/35 (2013)5789 of 05/09/2013
23/12/2013 Centralised - Renewal EMEA/H/C/802/R/34 (2013)9751 of 18/12/2013
17/12/2015 Centralised - Variation EMEA/H/C/802/IAin/40/G
Updated with Decision(2016)9023 of 23/12/2016
14/12/2016 Centralised - Variation EMEA/H/C/000802/IAIN/0044/G
04/01/2017 Centralised - Yearly update (2016)9023 of 23/12/2016