Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Raloxifene Teva   
Auth. number : EU/1/10/627
Active substance : Raloxifene hydrochloride
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03X - Other sex hormones and modulators of the genital system
Chemical subgroup: G03XC - Selective estrogen receptor modulators
Chemical substance: G03XC01 - Raloxifene
(See WHO ATC Index)
Indication: indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
03/05/2010 Centralised - Authorisation EMEA/H/C/1075 (2010)2936 of 29/04/2010
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1075//IB/1/G
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1075/II/2/G
15/02/2011 Centralised - Variation EMEA/H/C/1075/IA/3/G
Updated with Decision(2011)6523 of 13/09/2011
15/09/2011 Centralised - Variation (2011)6523 of 13/09/2011
11/05/2012 Centralised - Variation EMEA/H/C/1075/IB/5
Updated with Decision(2012)7930 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7930 of 29/10/2012
14/12/2012 Centralised - Notification EMEA/H/C/1075/N/7
Updated with Decision(2015)742 of 06/02/2015
12/03/2014 Centralised - Notification EMEA/H/C/1075/N/9
Updated with Decision(2015)742 of 06/02/2015
01/08/2014 Centralised - Variation EMEA/H/C/1075/IA/12/G
Updated with Decision(2015)742 of 06/02/2015
11/02/2015 Centralised - Renewal EMEA/H/C/1075/R/13 (2015)742 of 06/02/2015
29/06/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1075/T/17 (2015)3665 of 27/05/2015
29/07/2015 Centralised - Notification EMEA/H/C/1075/N/18
08/08/2016 Centralised - Variation EMEA/H/C/1075/IB/21/G
07/09/2016 Centralised - Variation EMEA/H/C/1075/IAIN/22