Regulatory PathRegulatory requirements compared

Active substance

Mangafodipir trisodium

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
TESLASCAN 0.01 MMOL-ML I.V Infusion*7.57 mg/mlSolution · Intravenous use1 VialSAR 627.25NCE · PrescriptionAMERSHAM HEALTH A.S.Invalid · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
TESLASCAN37.9MG/MLinjectable · injectionIC TARGETSDiscontinued26 Nov 1997

EMA European Union — centrally authorised medicines

Teslascan GE Healthcare AS · Withdrawn · authorised 22 May 1997 · ATC V08CA05

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only. Contrast medium for diagnostic magnetic resonance imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas. As an adjunct to MRI to aid in the investigation of focal pancreatic lesions.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.