Boehringer Ingelheim products’ risk/benefit profile confirmed by EU

Boehringer Ingelheim has announced that its products containing the active ingredients ambroxol and bromhexine have had their benefit/risk profiles confirmed in Europe.

The European Commission has confirmed the favourable risk profile of ambroxol and bromhexine-containing medicines via an EU-wide legally binding decision, with product information to be updated in line with this ruling.

This follows the opinion of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human, as well as a recommendation from the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency.

Ambroxol and bromhexine were researched and developed by Boehringer Ingelheim, and have been successfully on the market for more than 30 and 50 years, respectively. They are mainly used as preparations for the treatment of respiratory tract diseases.

David Wright, head of Boehringer Ingelheim's global consumer healthcare business, said: "The wellbeing of patients taking our medicines is the top priority for Boehringer Ingelheim, which is why we continuously monitor the safety profile of all our products."

This ruling means the company will be able to continue the sale of well-known brands such as Mucosolvan, Mucoangin and Bisolvon.