Nerlynx (neratinib)
- Region
- 🇪🇺 EU
- Active substance
- neratinib
- Company
- Pierre Fabre Medicament
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms
- CHMP opinion
- Thu 28 Jun 2018
- EU approval
- Fri 31 Aug 2018
- Application
- EMEA/H/C/004030
- ATC
- L01EH02
- Official record
- www.ema.europa.eu
Indication
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
Regulatory milestones
No milestones recorded in the last year.
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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.