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• Authorised

• Clinical trial using GSK525762 in combination with fulvestrant in subjects with breast cancer.
• ER-positive Breast Cancer MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Canada, France, Korea, Republic of, Spain, United Kingdom, United States
• 2017-01-03

• Authorised

• Phase 3 Study of Pembrolizumab/Epacadostat/Chemotherapy in Metastatic NSCLC
• First-line treatment of metastatic NSCLC MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
• 2018-03-12

• Authorised

• 201584 or “FLAIR” is a study to compare two drugs (called Cabotegravir and Rilpivirine, as oral tablets followed by long-acting injections) to a single tablet regimen containing 3 HIV drugs (called Triumeq)
• Human Immunodeficiency Virus type 1 (HIV-1) MedDRA version: 19.0 Level: LLT Classification code 10003582 Term: Asymptomatic human immunodeficiency virus type I infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Canada, France, Germany, Italy, Japan, Netherlands, Russian Federation, South Africa, Spain, United Kingdom, United States
• 2016-08-05

• Authorised

• A Phase III study to compare two drugs (called Cabotegravir and Rilpivirine, as oral tablets followed by long-acting injections) to current HIV regimens containing three drugs
• Human Immunodeficiency Virus type 1 (HIV-1) MedDRA version: 19.0 Level: LLT Classification code 10003582 Term: Asymptomatic human immunodeficiency virus type I infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Argentina, Australia, Canada, France, Germany, Italy, Korea, Democratic People's Republic of, Mexico, Russian Federation, South Africa, Spain, Sweden, United States
• 2016-08-05

• Authorised

• Phase 2 Study of Pembrolizumab/Epacadostat/Chemotherapy in Metastatic NSCLC
• First-line treatment of metastatic NSCLC MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Brazil, Canada, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Spain, Taiwan, Turkey, United Kingdom, United States
• 2017-11-22

• Authorised

• A study of Iclusig (ponatinib), an oral kinase-inhibitor treatment administered, by standard dose or reduced doses, for patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) who no longer benefit from, or who have an abnormal gene (T315I positive) marker for resistance to other kinase-inhibitor treatments.
• Chronic Phase Chronic Myeloid Leukemia MedDRA version: 20.0 Level: LLT Classification code 10054352 Term: Chronic phase chronic myeloid leukemia System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Argentina, Australia, Belgium, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Russian Federation, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States
• 2015-07-07

• Authorised

• An open study comparing the efficacy of S-1 and Cisplatin in combination versus 5-FU and Cisplatin in patients with Gastric cancer not previously treated with chemotherapy.
• Metastatic Diffuse Gastric Cancer MedDRA version: 17.0 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
• Argentina, Belgium, Brazil, Bulgaria, Colombia, Croatia, Estonia, Germany, Hungary, Italy, Lithuania, Mexico, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom, United States
• 2010-12-03

• Authorised

• A Phase 1/2 Study of Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are = 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy
• Acute Myelogenous Leukemia MedDRA version: 20.0 Level: LLT Classification code 10001941 Term: AML System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Australia, Germany, Italy, United States
• 2014-09-24

• Authorised

• The purpose of this study is to evaluate a drug (LUM001) that may help treat the liver and control itching in Alagille Syndrome. In this study, all children who are eligible to enrol will take study drug for 18 weeks, followed by a 4 week period where they will either take LUM001 or placebo. After this 4 week period, all patients will go back on active study drug treatment for the remaining 26 weeks.
• Alagille Syndrome br>MedDRA version: 17.0 Level: PT Classification code 10053870 Term: Alagille syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
• Australia, Canada, Spain
• 2014-05-22

• Authorised

• Study to collect data to further monitor whether the treatment triggers an immune reaction (i.e. development of antibodies, so called “inhibitors” directed against factor 8), to further investigate how well Human-cl rhFVIII prevents and stops bleeding episodes, and to monitor if it is safe and well tolerated in the treatment on a long-term basis.
• Severe Haemophilia A MedDRA version: 16.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
• Brazil, Canada, Colombia, France, Georgia, Germany, India, Moldova, Republic of, Morocco, Poland, Russian Federation, Spain, Ukraine, United Kingdom, United States, Venezuela, Bolivarian Republic of
• 2013-11-20