EC Confirms Use of Ambroxol and Bromhexine APIs

By Pharma News - DCAT Publisher

January 26, 2016

The European Commission (EC) has taken an European Union-wide legally binding decision and confirmed the favorable benefit/risk profile of ambroxol and bromhexine containing medicines. This decision follows the opinion of the Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh) as well as the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA).

The decision includes an update of the product information of all ambroxol and bromhexine containing products to include the rare risk of hypersensitivity reactions and a Precaution and Warning regarding severe cutaneous adverse reactions (SCARs).

Boehringer Ingelheim will update the respective product information in line with the EC's decision. All Boehringer Ingelheim products containing ambroxol and bromhexine remain available in their registered indications and age groups.Boehringer Ingelheim markets a number of brands containing ambroxol or bromhexine, including Mucosolvan and Mucoangin (active ingredient: ambroxol), Bisolvon (active ingredient: bromhexine) and, in a combination product, Spasmo-Mucosolvan (active ingredients: ambroxol and clenbuterol).

The active ingredients ambroxol and bromhexine were researched and developed by Boehringer Ingelheim, and have been successfully on the market for over 30 and 50 years respectively. They are used in various ways mainly as preparations for treatment of respiratory tract diseases. Most commonly they are used in medicines available over the counter in pharmacies for the management of productive cough.

Source: Boehringer Ingelheim