Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fareston   
Auth. number : EU/1/96/004
INN : Toremifene
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: L02BA02 - Toremifene
(See WHO ATC Index)
Indication: First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with estrogen receptor negative tumours.
Marketing Authorisation Holder: Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi

  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
16/02/1996 Centralised - Authorisation EMEA/H/C/91 (96)358 of 14/02/1996
04/10/1996 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/91/T (96)2367 of 02/10/1996
13/03/1998 Centralised - Variation EMEA/H/C/91/II/1 (1998)591 of 11/03/1998
30/06/1999 Centralised - Notification EMEA/H/C/91/N/5 (1999)1652 of 18/06/1999
17/09/1999 Centralised - Notification EMEA/H/C/91/N/7 (1999)2866 of 07/09/1999
24/01/2000 Centralised - Notification EMEA/H/C/91/N/8 (2000)37 of 20/01/2000
22/03/2001 Centralised - Variation EMEA/H/C/91/II/10 (2001)542 of 20/03/2001
19/05/2001 Centralised - Renewal EMEA/H/C/91/R/11 (2001)1242 of 18/05/2001
23/07/2002 Centralised - Notification EMEA/H/C/91/N/15 (2002)2839 of 18/07/2002
28/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/I/16
29/12/2003 Centralised - Notification EMEA/H/C/91/N/17 (2003)5318 of 22/12/2003
22/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/18
29/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/20
18/03/2005 Centralised - Notification EMEA/H/C/91/N/21
Updated with Decision(2006)334 of 02/02/2006
06/02/2006 Centralised - Renewal EMEA/H/C/91/R/22 (2006)334 of 02/02/2006
13/07/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/91/T/23 (2006)3249 of 11/07/2006
15/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IB/27
15/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IB/26
13/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/28
01/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/29
06/05/2008 Centralised - Variation EMEA/H/C/91/IA/30
Updated with Decision(2008)8810 of 17/12/2008
28/05/2008 Centralised - Notification EMEA/H/C/91/N/31
Updated with Decision(2008)8810 of 17/12/2008
22/12/2008 Centralised - Variation (2008)8810 of 17/12/2008
04/03/2009 Centralised - Variation EMEA/H/C/91/II/32 (2009)1581 of 02/03/2009
02/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/33
28/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IB/34, 35
28/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IB/35
21/01/2011 Centralised - Notification EMEA/H/C/91/N/36
Updated with Decision(2014)6198 of 26/08/2014
17/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/91/IA/37
21/02/2014 Centralised - Variation EMEA/H/C/91/IB/38
Updated with Decision(2014)6198 of 26/08/2014
28/08/2014 Centralised - Modification EMEA/H/C/91/PSUSA/2999/201309 (2014)6198 of 26/08/2014