Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Afinitor   
Auth. number : EU/1/09/538
Active substance : everolimus
Orphan market exclusivity for "Treatment of renal cell carcinoma" (based on designation EU/3/07/449) started on 05/08/2009
   10 years of market exclusivity
   This orphan market exclusivity has ended on 08/07/2011
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE10 - Everolimus
(See WHO ATC Index)
Indication: Hormone receptor-positive advanced breast cancer
Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Neuroendocrine tumours of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.
Renal cell carcinoma
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.
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
05/08/2009 Centralised - Authorisation EMEA/H/C/1038 (2009)6251 of 03/08/2009
15/10/2009 Centralised - Variation EMEA/H/C/1038/IB/1
Updated with Decision(2010)1828 of 15/03/2010
15/10/2009 Centralised - Variation EMEA/H/C/1038/IB/2
Updated with Decision(2010)1828 of 15/03/2010
10/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1038/IA/3
17/03/2010 Centralised - Variation (2010)1828 of 15/03/2010
01/04/2010 Centralised - Variation EMEA/H/C/1038/II/6 (2010)2246 of 30/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/1038/II/5 (2010)2851 of 27/04/2010
04/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1038/IB/7/G
13/01/2011 Centralised - Variation EMEA/H/C/1038/IG/32/G
Updated with Decision(2011)2251 of 28/03/2011
30/03/2011 Centralised - Variation (2011)2251 of 28/03/2011
16/06/2011 Centralised - Variation EMEA/H/C/1038/II/9/G (2011)4292 of 14/06/2011
08/07/2011 Centralised - (orphan status)
30/08/2011 Centralised - Variation EMEA/H/C/1038/II/8 (2011)6162 of 24/08/2011
24/11/2011 Centralised - Variation EMEA/H/C/1038/II/14 (2011)8689 of 22/11/2011
21/03/2012 Centralised - Variation EMEA/H/C/1038/II/15 (2012)1914 of 19/03/2012
25/07/2012 Centralised - Variation EMEA/H/C/1038/II/20 (2012)5347 of 23/07/2012
21/12/2012 Centralised - Variation EMEA/H/C/1038/X/17/G (2012)9865 of 18/12/2012
29/05/2013 Centralised - 2-Monthly update EMEA/H/C/1038/II/23/G (2013)3236 of 27/05/2013
25/07/2013 Centralised - Variation EMEA/H/C/1038/II/33
Updated with Decision(2014)3410 of 16/05/2014
25/07/2013 Centralised - Variation EMEA/H/C/1038/II/31
Updated with Decision(2014)3410 of 16/05/2014
22/10/2013 Centralised - Variation EMEA/H/C/1038/IAin/34
Updated with Decision(2014)3410 of 16/05/2014
24/10/2013 Centralised - Variation EMEA/H/C/1038/II/32
Updated with Decision(2014)3410 of 16/05/2014
21/11/2013 Centralised - Variation EMEA/H/C/1038/II/30
Updated with Decision(2014)3410 of 16/05/2014
20/05/2014 Centralised - Renewal EMEA/H/C/1038/R/36 (2014)3410 of 16/05/2014
25/09/2014 Centralised - Variation EMEA/H/C/1038/II/38
Updated with Decision(2014)10076 of 16/12/2014
23/10/2014 Centralised - Variation EMEA/H/C/1038/II/41
Updated with Decision(2014)10076 of 16/12/2014
18/12/2014 PSUSA - Modification EMEA/H/C/1038/PSUV/39 (2014)10076 of 16/12/2014
26/02/2015 Centralised - Variation EMEA/H/C/1038/II/43/G