Onivyde pegylated liposomal (previously Onivyde) (irinotecan hydrochloride trihydrate)
- Region
- 🇪🇺 EU
- Active substance
- irinotecan hydrochloride trihydrate
- Company
- Les Laboratoires Servier
- Status
- Authorised
- Therapeutic area
- Pancreatic Neoplasms
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Fri 14 Oct 2016
- Designations
- Orphan
- Application
- EMEA/H/C/004125
- ATC
- L01CE02
- Official record
- www.ema.europa.eu
Indication
ONIVYDE pegylated liposomal is indicated:- in combination with oxaliplatin, 5 fluorouracil (5 FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas,- in combination with 5-FU and LV for the treatment of metastatic adenocarcinoma of the pancreas, in adult patients who have progressed following gemcitabine based therapy.
Regulatory milestones
No milestones recorded in the last year.
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