Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 11 April 2018

Indication(s)

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.

Full Prescribing information

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More information

Category Value
Agency product number EMEA/H/C/000540
Orphan designation No
Date First Approved 10-03-2004
Type Medicinal product subject to medical prescription
Marketing authorisation holder AstraZeneca UK Ltd.