Medicinal products containing ambroxol and bromhexine: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and the Co-ordination group (CMDh) within a European safety review concerning the risk of hypersensitivity reactions
2015.03.10
Active substance: ambroxol | bromhexine
The BfArM issues information on a recommendation by the PRAC and the resulting majority decision by the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) within a European safety review in accordance with Article 31 of Directive 2001/83/EC.
To the risk assessment procedure (available in German only)
Details on the procedure can be found on the website of the European Medicines Agency (EMA):