The European Commission (EC) has taken an EU-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 Decentralised 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.
"We are very happy with this final decision of the European Commission," says David Wright, Head of the Boehringer Ingelheim Global CHC business. "The well-being 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. Decades of use in the marketplace as well as numerous clinical studies confirm that they are safe, effective, and well tolerated."
Boehringer Ingelheim markets a number of brands containing ambroxol or bromhexine; some of the most well-known brands include 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.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 percent of its net sales.
About Boehringer Ingelheim’s CHC activities
Boehringer Ingelheim Consumer Healthcare is the 8th largest Consumer Healthcare business in the world. Sales of Boehringer Ingelheim’s CHC business were €1.4 bn in 2014, contributing 11 per cent to Boehringer Ingelheim’s net sales. It aims to create and drive inspiring and sustainable solutions that will efficiently develop compelling and true global brands for consumers.
The leading brands of Boehringer Ingelheim’s CHC business are the antispasmodic Buscopan® (2014 sales of €219 million; mainly sold in Europe and Latin America), the laxative Dulcolax® (2014 sales of €204 million; sold in more than 40 countries with a strong presence in the U.S.), the multivitamins Pharmaton® (2014 sales of €133 million, with majority of sales in Latin America), the cough treatments Mucosolvan® (2014 sales of €165 million, mainly in China, Germany and Russia) and Bisolvon® (2014 sales of €101 million with a fragmented worldwide presence with largest countries being Spain and Italy) and the sore throat treatment Mucoangin®/Lysopaine® (2014 sales of €48 million).