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ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
Licence EU/1/16/1130/001 · Unknown
- Licence holder
- Les Laboratoires Servier (all products →)
- Active substance
- Irinotecan hydrochloride trihydrate
- Dosage form
- Concentrate for solution for infusion
- Route of administration
- Intravenous use
- ATC codes
- L01XX, L01XX19
- First authorised
- 14/10/2016
- Prescription status
- Product subject to prescription which may not be renewed (A)
- Supply
- Supply through pharmacies only
- Legal basis
- Full application (Article 8(3) of Directive No 2001/83/EC)
Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.