Revised SPC: Erythromycin ethyl succinate 250 mg/5 ml Granules for Oral Suspension
SPC updated with addition of a contraindication with lomitapide due to markedly increased transaminase levels with concomitant use, a warning to use with caution with corticosteroids and information on risk of congenital malformations after use during pregnancy.
Source:
electronic Medicines compendium
SPS commentary:
The changes follow recommendations from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).