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• Authorised

• A clinical study to investigate the efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the prevention of Acute Graft-versus-Host-Disease in adult and pediatric patients after allogeneic hematopoietic stem cell transplant
• Prevention of Acute Graft-versus-Host Disease (aGvHD) after allogeneic hematopoietic stem cell transplant MedDRA version: 20.0 Level: LLT Classification code 10068908 Term: AGVHD System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
• Belgium, Canada, France, Germany, Italy, Spain, Turkey, United Kingdom, United States
• 2017-12-27

• Authorised

• A Study to Evaluate the Efficacy, Safety, and Tolerability of Sildenafil Added to Pirfenidone in Patients with Advanced Idiopathic Pulmonary Fibrosis and Intermediate or High Probability of Pulmonary Hypertension due to the lung disease.
• "Pulmonary Hypertension in patients with Idiopathic pulmonary fibrosis (IPF) MedDRA version: 19.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
• Belgium, Canada, Czech Republic, Egypt, Germany, Greece, Hungary, Israel, Italy, Netherlands, South Africa, Spain, Turkey, United Arab Emirates
• 2016-09-09

• Authorised

• Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to a standard chemotherapy.
• Patients with first relapse or progression of aggressive Non-Hodgkin’s Lymphoma who are not eligible neither for autologous nor allogeneic stem cell transplantation MedDRA version: 20.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Austria, Belgium, Czech Republic, France, Germany, Israel, Netherlands, Poland, Portugal
• 2018-02-27

• Authorised

• An open-label extension study evaluating the safety and tolerability of leuco-methylthioninium dihydromesylate (LMTM) in subjects with Alzheimer's Disease or a rare form of dementia (Behavioral Variant Frontotemporal Dementia) who have completed an earlier Phase trial
• Alzheimer’s Disease and behavioral variant Frontotemporal Dementia MedDRA version: 19.0 Level: PT Classification code 10068968 Term: Frontotemporal dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Australia, Belgium, Bulgaria, Canada, Croatia, Finland, France, Germany, Korea, Republic of, Malaysia, Netherlands, Romania, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
• 2014-08-20

• Authorised

• DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL- TO-MILD ALZHEIMER’S DISEASE
• Alzheimer’s Disease (AD) MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
• 2016-05-26

• Authorised

• An Efficacy and Safety Study of Crenezumab in Patients with Prodromal to Mild Alzheimer’s Disease
• Alzheimer’s Disease MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Estonia, France, Germany, Greece, Guatemala, Israel, Italy, Japan, Korea, Democratic People's Republic of, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States
• 2017-01-03

• Authorised

• This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study. The efficacy and safety of investigated drug RVT-101 at a dose of 35 mg daily when used as an adjunct treatment to stable donepezil therapy will be evaluated over a 24-week treatment period for mild to moderate Alzheimer’s disease in patients on stable therapy with donepezil.
• Alzheimer’s Disease MedDRA version: 19.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czech Republic, France, Germany, Italy, Korea, Republic of, Malaysia, Poland, Serbia, Singapore, Slovakia, Spain, United Kingdom, United States
• 2015-11-11

• Authorised

• Study to assess long-term safety and efficacy of CDZ173 in patients with APDS/PASLI
• APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110d-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency);Therapeutic area: Diseases [C] - Immune System Diseases [C20]
• Belarus, Czech Republic, Ireland, Italy, Netherlands, Russian Federation, United Kingdom, United States
• 2016-05-25

• Authorised

• DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL- TO-MILD ALZHEIMER?S DISEASE
• Alzheimer?s Disease MedDRA version: 19.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States
• 2016-05-17

• Authorised

• A study to demonstrate the improvement in symptoms of constipation in subjects with cancer on non-cancer related pain requiring round the clock opioid therapy.
• The intended indication is: Severe pain, which can be adequately managed only with opioid analgesics. The opioid antagonist naloxone is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors locally in the gut. MedDRA version: 16.1 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
• Australia, Czech Republic, Denmark, Finland, Germany, India, Israel, Korea, Republic of, Romania, United Kingdom
• 2011-05-24