| Document Date: 2011-01-05 07:16:25
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City Study / / Company GlaxoSmithKline Laboratoires Rapporteur France / N 04BCO4 - Dopamine Agonists Pharmaceutical / the AEs / Glaxosmithkline plc / / Event FDA Phase / Product Recall / Product Issues / / Facility Member State ADARTREL INN / / IndustryTerm pharmaceutical formulation / pharmaceutical product / / MedicalCondition ADHD / severe idiopathic Restless Legs Syndrome / disease / headache / Restless Legs Syndrome / sleep terror disorder / primary sleep disorder / sleep disorder / nausea / shoulder injury / upper abdominal pain / RLS / orthostatic hypotension / vomiting / severe idiopathic/primary restless legs syndrome / dizziness / sleep walking disorder / renal failure / symptomatic orthostatic hypotension / e.g. narcolepsy / / MedicalTreatment contraception / / Movie Male and female / / Organization Ropinirole administration / IR administration / FDA / IR / CR administration / / Person Cmax / / Position investigator / treating physician / representative / / Product ropinirole CR-RLS / CR-RLS tablet / IR tablet / CL-RLS tablet / Ropinirole hydrochloride / Ropinirole IR / RLS / ropinirole / / Technology pharmacokinetics / amended protocol / /
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Rapporteur’s Public Assessment Report for paediatric studies submitted in accordance with Article 46 of Regulation (EC) No1901/2006, as amended