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Ambroxol and bromhexine: realisation of the EU Commission's implementing decision
2016.02.23
Active substance: ambroxol | bromhexine
On 14 January 2016, the European Commission decided to update the texts of the Summaries of Product Characteristics/Package Leaflets of medicinal products containing ambroxol and bromhexine.
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)