Synthroid – Range of tablets: Typing error in Professional Information (PI) and Patient Information Leaflet (PIL)

The DHCPL is intended to inform healthcare professionals (HCPs) about a typing error in the PI and PIL. The Synthroid products with PI and PIL with the typing error will not be distributed in the country for human use. Thus, Abbot applied for a Section 36 Exemption which allows supply of the Synthroid range of tablets sourced outside of South Africa. To prevent treatment interruptions in patients on the these tabelts and allow for the distribution of the products, SAHPRA has granted Abbott’s request for this Section 36 Exemption. The DHCPL is meant to alert HCPs about the difference in artwork between Synthroid tablets sourced outside the country to those registered in the country.