Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fablyn   
Auth. number : EU/1/08/500
INN : lasofoxifene
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: G03XC03 - Lasofoxifene
(See WHO ATC Index)
Indication: treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated
Marketing Authorisation Holder: Dr Friedrich Eberth Arzneimittel GmbH
Am Bahnhof 2, D-92289 Ursensollen, Deutschland

  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
25/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/977 (2009)1351 of 24/02/2009
26/02/2009 Centralised - Authorisation EMEA/H/C/977 (2009)1350 of 24/02/2009
30/07/2009 Centralised - Variation EMEA/H/C/977/II/1 (2009)6063 of 24/07/2009
08/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/977/IG/44/G
22/02/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/977/T/3 (2012)1196 of 17/02/2012