European authorities approve Medivir’s marketing authorisation application in 14 European countries

Regulatory News:

The European regulatory authorities have now approved Medivir’s marketing authorisation application in 14 European countries. The trademark for the product in Europe will be XerclearTM.

The label for XerclearTM, that is the approved indication text, is unique for a topical cold sore product in Europe:

”Treatment of early signs and symptoms of recurrent herpes labialis (cold sores) to reduce the progression of cold sore episodes to ulcerative lesions in immunocompetent adults and adolescents (12 years of age and older)”.

XerclearTM thus has a distinct competitive edge in Europe as well as US, where the product was approved on 31 July 2009 with a similarly strong label.

The remaining step in the process towards product launch in the 14 European countries takes place at the national level, and includes determination of the local packaging and OTC/RX status. This process is expected to be completed by year-end.