Lutathera (lutetium (177Lu) oxodotreotide)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- lutetium (177Lu) oxodotreotide
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Neuroendocrine Tumors
- CHMP opinion
- Thu 20 Jul 2017
- EU approval
- Tue 26 Sep 2017
- Designations
- Orphan
- Application
- EMEA/H/C/004123
- ATC
- V10XX04
- Official record
- www.ema.europa.eu
Indication
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP?NETs) in adults.
Regulatory milestones
No milestones recorded in the last year.
Follow Lutathera
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.