Medicinal product containing genetically modified organisms Immunological medicinal product (such as vaccine, allergen, immune serum)
one involving a medical device)Ĭommittee on Advanced therapies (CAT) has issued a classification for this productĬombination product that includes a device, but does not involve an Advanced Therapy
The IMP has been designated in this indication as an orphan drug in the Communityĭ.3.8 to D.3.10 IMP Identification Details (Active Substances)Īctive substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)Ĭombination ATIMP (i.e.
CTIVO 2.5.1 TRIAL
IMP to be used in the trial has a marketing authorisation Status of the IMP to be used in the clinical trial Trial is part of a Paediatric Investigation PlanĮMA Decision number of Paediatric Investigation Plan non-technical, languageĪ Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients with Diabetic Macular EdemaĮstudio para investigar la eficacia, seguridad, tolerabilidad, farmacocinética y farmacodinamia de RO7200220 administrado por vía intravítrea en pacientes con edema macular diabético Title of the trial for lay people, in easily understood, i.e. TOLERABILIDAD, FARMACOCINÉTICA Y FARMACODINÁMICA DE RO7200220 ADMINISTRADO POR VÍA INTRAVÍTREA EN PACIENTES CON EDEMA MACULAR DIABÉTICO A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH DIABETIC MACULAR EDEMAĮSTUDIO DE FASE II, MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO CONTROLADO CON TRATAMIENTO ACTIVO PARA INVESTIGAR LA EFICACIA, SEGURIDAD,
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