Sponsor: PharmaMar .
ClinicalTrials Identifier: NCT02566993
Updated: 2016_12_25 .
Health Authority: United States: Food and Drug Administration .
Lebanon: Ministry of Public Health .
Hungary: National Institute of Pharmacy .
Canada: Health Canada .
Czech Republic: State Institute for Drug Control .
Austria: Austrian Federal Office for Safety in Health Care .
Belgium: Federal Agency for Medicines and Health Products, FAMHP .
Brazil: National Health Surveillance Agency .
Portugal: INFARMED, National Authority of Medicines and Health Products, IP .
Spain: Agencia Española de Medicamentos y Productos Sanitarios .
Greece: National Organization of Medicines .
United Kingdom: Medicines and Healthcare Products Regulatory Agency .
Germany: Federal Institute for Drugs and Medical Devices .
Italy: The Italian Medicines Agency .
Bulgaria: Bulgarian Drug Agency .
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