THERAPEUTIC CLASS
Safety of ambroxol in the treatment of airway diseases in adult patients
Ambroxol is a widely used secretolytic and mucoactive over-the-counter agent primarily used to treat respiratory diseases associated with viscid mucus. Following post-marketing reports of hypersensitivity reactions and severe cutaneous adverse reactions (SCARs) possibly linked to ambroxol, the European Union’s Pharmacovigilance Risk Assessment Committee (PRAC) initiated in April 2014 a review of the safety of ambroxol in all its registered indications, which was finalized in 2016
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