Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Lucentis   
Auth. number : EU/1/06/374
Active substance : ranibizumab
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01L - Ocular vascular disorder agents
Chemical subgroup: S01LA - Antineovascularisation agents
Chemical substance: S01LA04 - Ranibizumab
(See WHO ATC Index)
Indication: Lucentis is indicated in adults for:
- The treatment of neovascular (wet) age-related macular degeneration (AMD)
- The treatment of visual impairment due to diabetic macular oedema (DME)
- The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
- The treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
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
24/01/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/715 (2007)238 of 22/01/2007
24/01/2007 Centralised - Authorisation EMEA/H/C/715 (2007)237 of 22/01/2007
27/04/2007 Centralised - Variation EMEA/H/C/715/IB/2
Updated with Decision(2007)5706 of 20/11/2007
07/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/II/1
19/06/2007 Centralised - Variation EMEA/H/C/715/IA/3
Updated with Decision(2007)5706 of 20/11/2007
22/11/2007 Centralised - Variation (2007)5706 of 20/11/2007
21/12/2007 Centralised - Variation EMEA/H/C/715/II/4 (2007)6772 of 19/12/2007
04/02/2008 Centralised - Variation EMEA/H/C/715/IB/5
Updated with Decision(2008)4953 of 02/09/2008
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/II/7
04/09/2008 Centralised - Variation EMEA/H/C/715/II/8 (2008)4953 of 02/09/2008
29/10/2008 Centralised - Variation EMEA/H/C/715/II/6 (2008)6416 of 27/10/2008
19/11/2008 Centralised - Variation EMEA/H/C/715/IB/10
Updated with Decision(2009)5020 of 17/06/2009
26/11/2008 Centralised - Variation EMEA/H/C/715/II/9 (2008)7501 of 24/11/2008
04/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/II/13
22/06/2009 Centralised - Variation (2009)5020 of 17/06/2009
01/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/IB/15
10/08/2009 Centralised - Variation EMEA/H/C/715/II/14 (2009)6352 of 06/08/2009
14/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/IB/16
07/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/IA/17
04/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/II/18
01/04/2010 Centralised - Variation EMEA/H/C/715/II/19 (2010)2255 of 30/03/2010
25/08/2010 Centralised - Variation EMEA/H/C/715/IB/21
Updated with Decision(2011)69 of 06/01/2011
21/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/715/IA/32/G
10/01/2011 Centralised - Variation EMEA/H/C/715/II/20 (2011)72 of 06/01/2011
11/01/2011 Centralised - Variation EMEA/H/C/715/II/20 (2011)69 of 06/01/2011
31/05/2011 Centralised - Variation EMEA/H/C/715/II/22/127a (MS) (2011)3886 of 27/05/2011
31/05/2011 Centralised - Variation EMEA/H/C/715/II/22/127a (MAH) (2011)3885 of 27/05/2011
06/09/2011 Centralised - Variation EMEA/H/C/715/II/23 (2011)6339 of 02/09/2011
19/12/2011 Centralised - Renewal EMEA/H/C/715/R/24 (2011)9753 of 14/12/2011
29/06/2012 Centralised - Variation EMEA/H/C/715/II/29 (2012)4489 of 27/06/2012
25/07/2012 Centralised - Variation EMEA/H/C/715/IB/32
Updated with Decision(2012)7899 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7899 of 29/10/2012
17/01/2013 Centralised - Variation EMEA/H/C/715/II/31
Updated with Decision(2013)4358 of 04/07/2013
01/03/2013 Centralised - Variation EMEA/H/C/715/IAin/39
Updated with Decision(2013)4358 of 04/07/2013
08/07/2013 Centralised - Variation EMEA/H/C/715/II/34 (2013)4358 of 04/07/2013
09/09/2013 Centralised - Variation EMEA/H/C/715/IA/41
Updated with Decision(2014)6360 of 04/09/2014
24/10/2013 Centralised - Variation EMEA/H/C/715/II/40/G
Updated with Decision(2014)6360 of 04/09/2014
23/01/2014 Centralised - Variation EMEA/H/C/715/II/43
Updated with Decision(2014)6360 of 04/09/2014
22/05/2014 Centralised - Variation EMEA/H/C/715/II/44
Updated with Decision(2014)6360 of 04/09/2014
20/08/2014 Centralised - Variation EMEA/H/C/715/IB/48
Updated with Decision(2015)5217 of 20/07/2015
08/09/2014 Centralised - 2-Monthly update EMEA/H/C/715/II/47 (2014)6360 of 04/09/2014
29/09/2014 Centralised - Variation EMEA/H/C/715/IA/50
Updated with Decision(2015)5217 of 20/07/2015
28/11/2014 Centralised - Variation EMEA/H/C/715/IB/51/G
Updated with Decision(2015)5217 of 20/07/2015
12/12/2014 Centralised - Variation EMEA/H/C/715/IA/52
Updated with Decision(2015)5217 of 20/07/2015
23/07/2015 Centralised - Yearly update (2015)5217 of 20/07/2015