Regulatory Decision Summary for Lipiodol Ultra Fluid
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to obtain marketing authorization for Lipiodol Ultra Fluid [ethiodized Oil Injection, House Standard (Std.)] for a new indication: selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).
Why was the decision issued?
This NDS was filed based on third-party data (literature and market experience).
Following selective injection into the hepatic artery or tumor feeding branches, Lipiodol Ultra Fluid accumulated in HCC tumor nodules. The radiocontrast property of Lipiodol Ultra Fluid allowed visualization of the tumor in computed tomography (CT) and various applications including transarterial (chemo) embolization procedures.
Lipiodol Ultra Fluid, selectively injected into the hepatic artery or tumor feeding branches can cause serious, life-threatening adverse reactions, including embolization of the lung, brain and other major organs, thyroid dysfunction, hypersensitivity, renal toxicity and aggravation of existing asthma. Cases of serious or fatal exacerbation of chronic liver disease, including hepatic failure were reported. There was evidence that Lipiodol Ultra Fluid use immediately before or during pregnancy can cause fetal harm.
To manage the serious adverse reactions, Lipiodol Ultra Fluid use was limited to health professionals experienced in the respective imaging procedure in a controlled clinical setting where adequate facilities and expertise for the management of serious adverse reactions are readily available. Furthermore, the Product Monograph (PM) was revised during the review to better articulate risk information and provide clearer instructions on patient selection and patient monitoring. A Risk Management Plan (RMP) was submitted and considered acceptable.
Health Canada considers the benefit of Lipiodol Ultra Fluid for the proposed indication outweighs associated harms and uncertainty.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| LIPIODOL ULTRA FLUID | 00386685 | GUERBET | IODINE (ETHIODIZED OIL) 380 MG / G |