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Authorised
Switching from Boosted Protease Inhibitor to Rilpivirine Combined with Tenofovir Disoproxil Fumarate/Emtricitabine
Human Immunodeficiency Virus (Type 1) Infection MedDRA version: 14.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Austria, Belgium, Canada, France, Germany, Italy, Puerto Rico, Spain, United Kingdom, United States
2010-11-02

Authorised
A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected patients that have not been treated yet.
Human Immunodeficiency Virus-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Argentina, Australia, Belgium, Canada, France, Germany, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Romania, Russian Federation, South Africa, Spain, Taiwan, Ukraine, United Kingdom, United States
2016-05-20

Authorised
A study to evaluate the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV- 1-infected patients that have not been treated yet.
Human Immunodeficiency Virus-1 infection MedDRA version: 20.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Argentina, Australia, Belgium, Canada, France, Germany, Italy, Mexico, Peru, Poland, Portugal, Romania, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Ukraine, United Kingdom, United States
2016-05-25

Authorised
A study to assess the effectiveness of the drug lucitanib in lung cancer patients
FGFR1-amplified squamous non-small cell lung cancer (NSCLC) MedDRA version: 16.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
France, Germany, Italy, Spain, United States
2014-03-03

Authorised
A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bulgaria, Colombia, Czech Republic, Hungary, India, Korea, Republic of, Lithuania, Mexico, Poland, Ukraine, United Kingdom
2013-02-20

Authorised
Study Brand Name : REPARO Study full title: An 8-week phase I/II, multicenter, randomized, double-masked, vehicle controlled parallel group study with a 48 or 56 week follow-up period to evaluate the safety and efficacy of two doses (10 µg/ml and 20 µg/ml) of recombinant human nerve growth factor eye drops solution versus vehicle in patients with Stage 2 and 3 of neurotrophic keratitis
Adult patients diagnosed with unilateral stage 2 (persistent epithelial defect) and stage 3 (corneal ulcer) NK refractory to one or more conventional non-surgical treatments. Patients with Controlateral eye affected with stage 1 NK can be enrolled. MedDRA version: 18.0 Level: LLT Classification code 10032064 Term: Other forms of keratitis System Organ Class: 100000004853 ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Belgium, Germany, Hungary, Poland, Portugal, Spain, United Kingdom, United States
2012-12-04

Authorised
Low dose tranexamic acid for craniosynostosis surgery
craniosynostosis MedDRA version: 17.0 Level: PT Classification code 10049889 Term: Craniosynostosis System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Italy, United States
2014-09-29

Authorised
A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed.
Human immunodeficiency virus type 1 (HIV-1) MedDRA version: 17.1 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, Belgium, Canada, France, Germany, Italy, Netherlands, Russian Federation, Spain, Taiwan, United Kingdom, United States
2015-04-14

Authorised
A Phase III, randomized, multicenter, parallel-group, noninferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current INI-, NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed
Human immunodeficiency virus type 1 (HIV-1) MedDRA version: 17.1 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, Belgium, Canada, France, Germany, Italy, Netherlands, Russian Federation, Spain, Taiwan, United Kingdom, United States
2015-04-14

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