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Marketing Authorization Holder GERDA LABORATORIES 24 RUE ERLANGER 75016 PARIS Operator of the marketing authorization GERDA LABORATORIES 24 RUE ERLANGER 75016 PARIS Maker DELPHARM TOURS LA BARAUDIERE 37170 CHAMBRAY LES TOURS or HAUPT PHARMA LIVRON 1 STREET COUNTY SINARD 26250 LIVRON-SUR-DROME Names of the drug in the member states of the European Economic Area Not applicable