Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Opgenra   
Auth. number : EU/1/08/489
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: Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
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 proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/819 (2009)1243 of 19/02/2009
23/02/2009 Centralised - Authorisation EMEA/H/C/819 (2009)1242 of 19/02/2009
28/04/2009 Centralised - Variation EMEA/H/C/819/IB/2
Updated with Decision(2009)5830 of 16/07/2009
13/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/II/3
21/07/2009 Centralised - Variation EMEA/H/C/819/II/1 (2009)5830 of 16/07/2009
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/IB/6
10/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/II/5
13/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/II/7
05/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/II/9
14/06/2010 Centralised - Variation EMEA/H/C/819/II/4 (2010)3892 of 10/06/2010
15/06/2010 Centralised - Variation EMEA/H/C/819/II/4 (2010)3891 of 10/06/2010
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/WS/50
21/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/WS/57
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/WS/77/G
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/819/WS/65/G
31/03/2011 Centralised - Variation EMEA/H/C/819/IA/11
Updated with Decision(2011)4287 of 14/06/2011
16/06/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/819/T/12 (2011)4287 of 14/06/2011
19/09/2011 Centralised - Variation EMEA/H/C/819/IA/13/G
Updated with Decision(2012)2837 of 20/04/2012
29/02/2012 Centralised - Variation EMEA/H/C/819/IA/22/G
Updated with Decision(2012)2837 of 20/04/2012
24/04/2012 Centralised - Variation (2012)2837 of 20/04/2012
08/01/2013 Centralised - Variation EMEA/H/C/819/IB/27
Updated with Decision(2013)8340 of 20/11/2013
22/03/2013 Centralised - Variation EMEA/H/C/819/IB/28
Updated with Decision(2013)8340 of 20/11/2013
25/11/2013 Centralised - Renewal EMEA/H/C/819/R/33 (2013)8340 of 20/11/2013
18/02/2014 Centralised - Variation EMEA/H/C/819/IG/411/G
Updated with Decision(2015)754 of 06/02/2015
20/02/2014 Centralised - Variation EMEA/H/C/819/WS/452
Updated with Decision(2015)754 of 06/02/2015
22/08/2014 Centralised - Variation EMEA/H/C/819/IG/473/G
Updated with Decision(2015)754 of 06/02/2015
10/02/2015 Centralised - Yearly update (2015)754 of 06/02/2015