The Committee recommended that the strength of iodine capsules in the EML and EMLc be corrected to 190 mg, to accurately reflect the quantitative composition as described in the marketing authorization and Summary of
Product Characteristics (SmPC).
Iodine capsules 200 mg and iodized oil were added to the EML in 1990 for the prophylaxis of goitre in areas where severe iodine deficiency is endemic and where dietary intake of iodine, including iodized salt, is inadequate (1). The same formulations were included on the first EMLc in 2007 (2).
The application requested a correction to the strength of iodine capsules listed on the EML and EMLc
A discrepancy exists between the listed strength of iodine capsules on the EML and EMLc and the marketing authorization of the product.
The marketing authorization and Summary of Product Characteristics (SmPC) for the product marketed by Guebet report the qualitative and quantitative composition as 500 mg ethyl esters of iodised fatty acids from poppy seed oil, corresponding to 190 mg iodine (38% w/w).
1. The use of essential drugs. Report of the WHO Expert Committee, 1990 (WHO Technical Report Series, No. 796). Geneva: World Health Organization; 1990. Available from https://apps.who.int/iris/bitstream/handle/10665/39338/WHO_TRS_796.pdf, accessed 30 October 2019.
2. The selection and use of essential medicines. Report of the WHO Expert Committee, October 2007 (including the Model List of Essential Medicines for Children) (WHO Technical Report Series, No. 950). Geneva: World Health Organization; 2008. Available from https://apps.who.int/iris/bitstream/handle/10665/43745/WHO_TRS_946_eng.pdf, accessed 30 October 2019.