Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Optruma   
Auth. number : EU/1/98/074
INN : 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: OPTRUMA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.When determining the choice of OPTRUMA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, 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
06/08/1998 Centralised - Authorisation EMEA/H/C/185 (1998)2459 of 05/08/1998
18/05/1999 Centralised - Variation EMEA/H/C/185/N/2 (1999)1296 of 11/05/1999
18/06/1999 Centralised - Variation EMEA/H/C/185/I/1 (1999)1607 of 11/06/1999
02/02/2000 Centralised - Variation EMEA/H/C/185/II/4 (2000)126 of 31/01/2000
27/03/2000 Centralised - Variation EMEA/H/C/185/II/3 (2000)769 of 24/03/2000
27/07/2000 Centralised - Variation EMEA/H/C/185/I/5
08/03/2001 Centralised - Variation EMEA/H/C/185/I/6 (2001)314 of 06/03/2001
01/06/2001 Centralised - Variation EMEA/H/C/185/I/8
27/07/2001 Centralised - Variation EMEA/H/C/185/N/11 (2001)2036 of 26/07/2001
01/11/2001 Centralised - Variation EMEA/H/C/185/II/7 (2001)2984 of 31/10/2001
18/04/2002 Centralised - Variation EMEA/H/C/185/I/13
23/04/2002 Centralised - Variation EMEA/H/C/185/N/12 (2002)1574 of 19/04/2002
28/10/2002 Centralised - Variation EMEA/H/C/185/II/10
11/11/2002 Centralised - Variation EMEA/H/C/185/N/19 (2002)4432 of 07/11/2002
13/11/2002 Centralised - Variation EMEA/H/C/185/I/18
04/02/2003 Centralised - Variation EMEA/H/C/185/N/21 (2003)463 of 31/01/2003
18/02/2003 Centralised - Variation EMEA/H/C/185/I/22 (2003)598 of 14/02/2003
15/05/2003 Centralised - Variation EMEA/H/C/185/I/25, 26
30/06/2003 Centralised - Variation EMEA/H/C/185/II/20 (2003)2122 of 26/06/2003
30/07/2003 Centralised - Renewal EMEA/H/C/185/R/23 (2003)2818 of 28/07/2003
16/06/2004 Centralised - Variation EMEA/H/C/185/N/27
Updated with Decision(2006)5355 of 31/10/2006
17/06/2004 Centralised - Variation EMEA/H/C/185/IA/28
22/06/2004 Centralised - Variation EMEA/H/C/185/IA/30
02/07/2004 Centralised - Variation EMEA/H/C/185/IB/29
08/10/2004 Centralised - Variation EMEA/H/C/185/IB/31
11/10/2004 Centralised - Variation EMEA/H/C/185/N/32
Updated with Decision(2006)5355 of 31/10/2006
05/12/2005 Centralised - Variation EMEA/H/C/185/N/33
Updated with Decision(2006)5355 of 31/10/2006
23/03/2006 Centralised - Variation EMEA/H/C/185/IB/34
Updated with Decision(2006)5355 of 31/10/2006
05/04/2006 Centralised - Variation EMEA/H/C/185/IB/35
13/04/2006 Centralised - Variation EMEA/H/C/185/IA/36
Updated with Decision(2006)5355 of 31/10/2006
24/05/2006 Centralised - Variation EMEA/H/C/185/IB/35
24/07/2006 Centralised - Variation EMEA/H/C/185/IB/38
12/10/2006 Centralised - Variation EMEA/H/C/185/N/40
Updated with Decision(2006)5727 of 22/11/2006
18/10/2006 Centralised - Variation EMEA/H/C/185/N/37
Updated with Decision(2006)5355 of 31/10/2006
06/11/2006 Centralised - Variation (2006)5355 of 31/10/2006
24/11/2006 Centralised - Variation EMEA/H/C/185/II/39 (2006)5727 of 22/11/2006
05/12/2006 Centralised - Variation EMEA/H/C/185/IB/41
29/01/2007 Centralised - Variation EMEA/H/C/185/N/42
Updated with Decision(2007)1495 of 27/03/2007
12/02/2007 Centralised - Variation EMEA/H/C/185/N/44
Updated with Decision(2007)1495 of 27/03/2007
30/03/2007 Centralised - Variation EMEA/H/C/185/II/43 (2007)1495 of 27/03/2007
04/05/2007 Centralised - Variation EMEA/H/C/185/IB/45
Updated with Decision(2007)5662 of 19/11/2007
21/09/2007 Centralised - Variation EMEA/H/C/185/IB/47
21/11/2007 Centralised - Variation (2007)5662 of 19/11/2007
05/12/2007 Centralised - Variation EMEA/H/C/185/IB/48
08/02/2008 Centralised - Variation EMEA/H/C/185/IB/49
Updated with Decision(2008)4429 of 11/08/2008
08/02/2008 Centralised - Variation EMEA/H/C/185/IB/50
20/02/2008 Centralised - Variation EMEA/H/C/185/IA/54
22/02/2008 Centralised - Variation EMEA/H/C/185/IA/53
Updated with Decision(2008)4429 of 11/08/2008
09/04/2008 Centralised - Variation EMEA/H/C/185/IB/55
13/08/2008 Centralised - Renewal EMEA/H/C/185/R/52 (2008)4429 of 11/08/2008
26/11/2008 Centralised - Variation EMEA/H/C/185/IA/56
21/12/2009 Centralised - Variation EMEA/H/C/185/N/57
Updated with Decision(2012)6141 of 30/08/2012
24/03/2010 Centralised - Variation EMEA/H/C/185/IB/58
24/03/2010 Centralised - Variation EMEA/H/C/185/IB/59
06/01/2011 Centralised - Variation EMEA/H/C/185/IA/60
03/09/2012 Centralised - Variation EMEA/H/C/185/II/62 (2012)6141 of 30/08/2012