Ibrance (palbociclib)
- Region
- 🇪🇺 EU
- Active substance
- palbociclib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 15 Sep 2016
- EU approval
- Wed 09 Nov 2016
- Application
- EMEA/H/C/003853
- ATC
- L01EF01
- Official record
- www.ema.europa.eu
Indication
Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy 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
- 🇪🇺 Palbociclib Viatris Authorised · Viatris 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.