The registration is conditional on provision of a clinical study plan, as part of the Risk Management Plan (RMP), outlining planned confirmatory data collection within a maximum of 6 years post registration
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By way of example, active principles which are of interest in the pharmaceutical industry are chosen, in a non-limiting manner, from antirheumatic, non-steroidal anti-inflammatory (e.g., NSAIDs), analgesic, antitussive and psychotropic agents, steroids, barbiturates, antimicrobial, antiallergenic, antiasthmatic, antispasmodic, antisecretory and cardiovascular agents, cerebral vasodilators, cerebral and hepatic protective agents, therapeutic agents of the gastrointestinal tract, anticancer or antiviral agents, vitamins, contraceptives, vaccines, etc
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Current protocols recommend treating patients with an initial dose of 150 mg/kg NAC, infused over a period of an hour, upon hospitalization, followed by decreasing amounts of NAC infused over the next 20 hours[1]
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