#SFHS2610278AFrance updates public-sector approval for ONIVYDE and expands its covered use
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This order updates the official listing for ONIVYDE in France’s list of medicines approved for use by public hospitals and other public services. The medicine’s label is changed from ONIVYDE 5 mg/ml to ONIVYDE PEGYLATED LIPOSOMAL 4.3 mg/ml, with the same CIP code and presentation.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Changes the official label of ONIVYDE under CIP code 34009 300 741 5 2.
- Expands coverage to first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.
- Specifies use in combination with oxaliplatin, 5-fluorouracil, and leucovorin.
Obligations
What this law requires
Public hospitals and other public services using the official list of approved pharmaceutical specialties must treat the listed ONIVYDE entry under CIP code 34009 300 741 5 2 as renamed to “ONIVYDE PEGYLATED LIPOSOMAL 4.3 mg/ml, solution à diluer pour perfusion en flacon en verre de 10 ml (B/1 flacon) (Laboratoires SERVIER).”
Public hospitals and other public services may apply coverage for ONIVYDE PEGYLATED LIPOSOMAL 4.3 mg/ml, CIP code 34009 300 741 5 2, for its extended indication in combination with oxaliplatin, 5-fluorouracil and leucovorin as first-line treatment for adult patients with metastatic pancreatic adenocarcinoma.