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  • Regulatory NewsRegulatory News

    EU Committee Wants Additional Restrictions on Codeine Use in Children

    A European committee is recommending a series of restrictions on the use of medicines containing codeine in children. PRAC’s Recommendations Citing concerns that codeine can cause breathing problems and other serious adverse effects in children, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is recommending codeine be contraindicated for children less than 12 years of age. Additionally, PRAC says that children between ages 12 ...