Fulvestrant Mylan (fulvestrant)
Generic
- Region
- 🇪🇺 EU
- Active substance
- fulvestrant
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Fri 09 Nov 2007
- EU approval
- Mon 08 Jan 2018
- Designations
- Generic
- Application
- EMEA/H/C/004649
- ATC
- L02BA03
- Official record
- www.ema.europa.eu
Indication
Fulvestrant is indicated 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 anti-estrogen therapy, or disease progression on antiestrogen therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Faslodex Authorised · AstraZeneca AB
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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.