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Pharmaceuticals - Community Register
Community list of not active medicinal products for human use |
WITHDRAWN |
Product information |
Invented name: | Osigraft |
Auth. number : | EU/1/01/179 |
Active substance : | eptotermin alfa |
ATC: | Anatomical main group: M - Musculo-skeletal system Therapeutic subgroup: M05 - Drugs for treatment of bone diseases Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization Chemical subgroup: M05BC - Bone morphogenetic proteins Chemical substance: M05BC02 - eptotermin alfa (See WHO ATC Index) |
Indication: | Treatment of non-union of tibia of at least 9 month duration, secondary to trauma, in skeletally mature patients, in cases where previous treatment with autograft has failed or use of autograft is unfeasible. |
Marketing Authorisation Holder: | Olympus Biotech International Limited
40 Upper Mount Street, Dublin 2, Ireland |
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 procedures |
Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
18/05/2001 | Centralised - Authorisation | EMEA/H/C/293 | (2001)1228 of 17/05/2001 | |||
24/07/2001 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/6 | ||||
24/07/2001 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/1, 5, 7 | ||||
24/07/2001 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/3 | ||||
31/07/2001 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/2 | ||||
28/01/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/8 | ||||
31/07/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/11 | ||||
10/09/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/12 | ||||
10/09/2002 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/13 | ||||
05/10/2002 | Centralised - Variation | EMEA/H/C/293/I/10 | (2002)3371 of 03/10/2002 | |||
14/11/2002 | Centralised - Variation | EMEA/H/C/293/I/14 | (2002)4498 of 12/11/2002 | |||
14/04/2003 | Centralised - Variation | EMEA/H/C/293/II/9 | (2003)1245 of 08/04/2003 | |||
21/11/2003 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/I/16 | ||||
16/12/2003 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/15 | ||||
30/03/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/17 | ||||
08/06/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/18 | ||||
02/08/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/20 | ||||
02/08/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/19 | ||||
22/09/2004 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/21 | ||||
01/06/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/22 | ||||
02/06/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/23 | ||||
04/07/2005 | Centralised - Variation | EMEA/H/C/293/II/25 | (2005)2088 of 28/06/2005 | |||
20/11/2005 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/IA/30 | ||||
28/02/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/29 | ||||
03/05/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/26 | ||||
03/05/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/27 | ||||
24/05/2006 | Centralised - Renewal | EMEA/H/C/293/R/28 | (2006)2118 of 19/05/2006 | |||
24/10/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/31 | ||||
19/12/2006 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/32 | ||||
23/02/2007 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/35 | ||||
04/05/2007 | Centralised - Variation | EMEA/H/C/293/II/33 | (2007)2024 of 02/05/2007 | |||
25/09/2007 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/37 | ||||
05/02/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/36 | ||||
04/03/2008 | Centralised - Variation | EMEA/H/C/293/II/34 | (2008)877 of 29/02/2008 | |||
04/04/2008 | Centralised - Variation | EMEA/H/C/293/II/38 | (2008)1317 of 02/04/2008 | |||
20/05/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/IA/39 | ||||
01/10/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/40 | ||||
02/10/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/IA/41 | ||||
09/10/2008 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/IA/42 | ||||
28/04/2009 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/43 | ||||
02/07/2009 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/44 | ||||
20/07/2009 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/IB/46 | ||||
22/10/2009 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/45 | ||||
23/03/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/48 | ||||
27/04/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/II/50 | ||||
28/07/2010 | Centralised - Variation | EMEA/H/C/293/IB/51 | ||||
Updated with Decision(2011)1508 of 28/02/2011 | ||||||
29/07/2010 | Centralised - Variation (rejected) | EMEA/H/C/293/II/47 | (2010)5322 of 27/07/2010 | |||
21/10/2010 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/WS/50 | ||||
20/01/2011 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/WS/57 | ||||
04/03/2011 | Centralised - Variation | (2011)1508 of 28/02/2011 | ||||
17/03/2011 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/WS/64/G | ||||
23/03/2011 | Centralised - Variation (no change in Commission Decision) | EMEA/H/C/293/WS/77/G | ||||
31/03/2011 | Centralised - Variation | EMEA/H/C/293/IA/54 | ||||
Updated with Decision(2011)6143 of 24/08/2011 | ||||||
04/05/2011 | Centralised - Renewal | EMEA/H/C/293/R/53 | (2011)3093 of 02/05/2011 | |||
30/08/2011 | Centralised - Transfer Marketing Authorisation Holder | EMEA/H/C/293/T/55 | (2011)6143 of 24/08/2011 | |||
20/10/2011 | Centralised - Variation | EMEA/H/C/293/IA/56/G | ||||
Updated with Decision(2012)3755 of 01/06/2012 | ||||||
29/02/2012 | Centralised - Variation | EMEA/H/C/293/IA/64/G | ||||
Updated with Decision(2012)3755 of 01/06/2012 | ||||||
05/06/2012 | Centralised - Variation | (2012)3755 of 01/06/2012 | ||||
22/01/2013 | Centralised - Variation | EMEA/H/C/293/IB/67 | ||||
Updated with Decision(2014)1684 of 10/03/2014 | ||||||
28/01/2014 | Centralised - Variation | EMEA/H/C/293/IG/411/G | ||||
Updated with Decision(2014)1684 of 10/03/2014 | ||||||
20/02/2014 | Centralised - Variation | EMEA/H/C/293/WS/452 | ||||
Updated with Decision(2014)1684 of 10/03/2014 | ||||||
12/03/2014 | Centralised - Yearly update | (2014)1684 of 10/03/2014 | ||||
22/08/2014 | Centralised - Notification | EMEA/H/C/293/IG/473/G | ||||
Updated with Decision(2015)5461 of 28/07/2015 | ||||||
30/07/2015 | Centralised - Yearly update | (2015)5461 of 28/07/2015 | ||||
21/12/2015 | Centralised - Withdrawal | (2015)9637 of 16/12/2015 |