EMA: Meeting highlights from the PRAC 6-9 January 2015
PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small
The Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing ambroxol or bromhexine, and has concluded that the risk of severe allergic reactions is small, but that the product information should be updated.
The PRAC recommended adding a new warning, together with advice to discontinue treatment immediately if symptoms of allergy or severe skin reactions occur.
Posted on the EMA website on 12 January 2015