Faslodex (fulvestrant)
- Region
- 🇪🇺 EU
- Active substance
- fulvestrant
- Company
- AstraZeneca AB
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- EU approval
- Tue 09 Mar 2004
- Application
- EMEA/H/C/000540
- ATC
- L02BA03
- Official record
- www.ema.europa.eu
Indication
Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Fulvestrant Mylan Authorised · Mylan Pharmaceuticals Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.