Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Faslodex   
Auth. number : EU/1/03/269
INN : Fulvestrant
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L02 - Endocrine therapy
Pharmacological subgroup: L02B - Hormone antagonists and related agents
Chemical subgroup: L02BA - Anti-estrogens
Chemical substance: L02BA03 - Fulvestrant
(See WHO ATC Index)
Indication: Treatment of postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant anti-estrogen therapy or disease progression on therapy with an anti-estrogen
Marketing Authorisation Holder: AstraZeneca UK Limited
Alderley Park, Macclesfield, Cheshire, SK10 4TG 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 continues to be 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
12/03/2004 Centralised - Authorisation EMEA/H/C/540 (2004)851 of 10/03/2004
15/07/2005 Centralised - Variation EMEA/H/C/540/II/2, 3 (2005)2671 of 05/07/2005
25/10/2005 Centralised - Variation EMEA/H/C/540/N/4
Updated with Decision(2006)5118 of 20/10/2006
27/01/2006 Centralised - Variation EMEA/H/C/540/IA/7
20/02/2006 Centralised - Variation EMEA/H/C/540/IB/6
20/02/2006 Centralised - Variation EMEA/H/C/540/IB/5
24/10/2006 Centralised - Variation EMEA/H/C/540/II/8 (2006)5118 of 20/10/2006
18/10/2007 Centralised - Variation EMEA/H/C/540/IA/10
18/10/2007 Centralised - Variation EMEA/H/C/540/IA/12
22/11/2007 Centralised - Variation EMEA/H/C/540/IB/11
22/11/2007 Centralised - Variation EMEA/H/C/540/IB/9
22/05/2008 Centralised - Variation EMEA/H/C/540/N/13
Updated with Decision(2008)8734 of 16/12/2008
23/09/2008 Centralised - Variation EMEA/H/C/540/IA/15
23/09/2008 Centralised - Variation EMEA/H/C/540/IA/16
18/12/2008 Centralised - Renewal EMEA/H/C/540/R/14 (2008)8734 of 16/12/2008
17/03/2010 Centralised - Variation EMEA/H/C/540/II/17 (2010)1767 of 15/03/2010
22/04/2010 Centralised - Variation EMEA/H/C/540/IA/21
22/04/2010 Centralised - Variation EMEA/H/C/540/IA/20
22/04/2010 Centralised - Variation EMEA/H/C/540/IA/19
26/04/2010 Centralised - Variation EMEA/H/C/540/IA/23
26/04/2010 Centralised - Variation EMEA/H/C/540/IB/22
Updated with Decision(2010)7524 of 25/10/2010
26/04/2010 Centralised - Variation EMEA/H/C/540/IA/24
27/10/2010 Centralised - Variation EMEA/H/C/540/II/18 (2010)7524 of 25/10/2010
21/01/2011 Centralised - Variation EMEA/H/C/540/IG/35
Updated with Decision(2011)5592 of 27/07/2011
01/08/2011 Centralised - Variation EMEA/H/C/540/II/25 (2011)5592 of 27/07/2011
22/02/2012 Centralised - Variation EMEA/H/C/540/II/33, 34 (2012)1190 of 17/02/2012
14/12/2012 Centralised - Variation EMEA/H/C/540/IB/37
Updated with Decision(2013)9755 of 18/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/540/II/36
Updated with Decision(2013)9755 of 18/12/2013
13/09/2013 Centralised - Variation EMEA/H/C/540/N/40
Updated with Decision(2013)9755 of 18/12/2013
23/12/2013 Centralised - Variation (2013)9755 of 18/12/2013