During an ongoing procedure in another country for label update for Tegretol® 100 mg/5ml Oral Suspension, the process triggered an assessment of the amount of propylene glycol in the product. Propylene Glycol, an excipient used in this product formulation, was found to be above the threshold of (1 mg/kg/day) for neonates (refer to respective EMA guideline “Excipients in the labelling and package leaflet of medicinal products for human use”). The benefits do not outweigh the potential risks due to the amount of propylene glycol and therefore Tegretol® 100 mg/5ml Oral Suspension use is no longer recommended in neonates. A label update to the relevant sections in the product information and patient leaflet for Tegretol® 100 mg/5ml Oral Suspension is in process to restrict its use in neonates.