CHMP recommends approval of Nuceiva in glabellar lines
Evolus announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Nuceiva (botulinum toxin type A formulation) marketing authorization application for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
The CHMP opinion is a scientific recommendation for marketing authorization to the European Commission, which will now review the recommendation and deliver its final decision on the Company’s marketing authorization application. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein. Nuceiva is branded Jeuveau in the United States.
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