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• Authorised

• SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
• Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant;Therapeutic area: Diseases [C] - Cancer [C04]
• Belgium, Czech Republic, France, Spain, United Kingdom
• 2016-06-20

• Authorised

• A study to assess two treatment regimes of injectable hormones, Gonadotrophins, which are used to treat fertility problems in women, in the effectiveness of inducing egg stimulation in women who are unable to ovulate by themselves.
• Anovulation in women with PCOS MedDRA version: 16.1 Level: PT Classification code 10033312 Term: Ovulation induction System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 16.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872 ;Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
• United Kingdom
• 2013-01-22

• Authorised

• TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE
• Inflammatory bowel disease MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
• United Kingdom
• 2011-07-16

• Authorised

• Dose escalating study to evaluate pharmacokinetics, efficacy and safety of apotransferrin in atransferrinemia patients. Estudio de escalada de dosis para evaluar la farmacocinÊtica, la eficacia y la seguridad de apotransferrina, en pacientes con atransferrinemia. - Apotransferrin replacement in atransferrinemia
• Atransferrinemia MedDRA version: 12.1 Level: LLT Classification code 10044357 Term: Transferrin increased MedDRA version: 12.1 Level: LLT Classification code 10005620 Term: Blood iron increased MedDRA version: 12.1 Level: LLT Classification code 10002272 Term: Anemia
• Germany, Spain
• 2010-06-28

• Authorised

• Role of a switch to an once-daily regimen of antiretroviral therapy on HIV-DNA levels and immune activation.
• Human Immunodeficiency Virus (HIV-1) Infection;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Italy
• 2014-10-23

• Authorised

• A double blind randomized controlled trial comparing the efficacy of two anaesthetic creams for local anaesthesia during laser treatment.
• Pain during laser treatment of: 1. Tattoo 2. Acne keloidalis nuchae;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
• Netherlands
• 2014-10-01

• Authorised

• Diagnostic use of 99mTecnetium labeled infliximab in Crohn’s disease
• Crohn’s disease MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Hungary
• 2014-06-11

• Authorised

• 200056 is a study testing the ability of two investigational drugs called GSK744 and TMC278, as either tablets or injections, to keep your HIV virus after initially getting HIV virus low using GSK744 tablets plus Epzicom / Kivexa
• HIV-1-infected adult subjects MedDRA version: 16.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Canada, France, Germany, Spain, United States
• 2014-03-06

• Authorised

• 200056 is a study testing the ability of two investigational drugs called GSK744 and TMC278, as either tablets or injections, to keep your HIV virus after initially getting HIV virus low using GSK744 tablets plus Epzicom / Kivexa
• HIV-1-infected adult subjects MedDRA version: 20.1 Level: LLT Classification code 10008922 Term: Chronic infection with HIV System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Virus Diseases [C02]
• Canada, France, Germany, Spain, United States
• 2014-02-21

• Authorised

• Changes in genes associated with metformin intolerance
• We want to investigate the pharmacokintetics of metformin in patients with type 2 diabetes or polycystic ovary syndrome in association with the patients genotype;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
• Austria
• 2014-01-13

• Authorised

• A Phase III gene therapy clinical trial in LHON Subjects Affected for more than 7months or more
• Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11]
• France, Germany, Italy, United Kingdom, United States
• 2015-08-11

• Authorised

• A Phase III gene therapy clinical trial in LHON Subjects Affected for 6 Months or Less
• Leber Hereditary Optic Neuropathy due to mutations in the mitochondrial NADH Dehydrogenase 4 gene;Therapeutic area: Diseases [C] - Eye Diseases [C11]
• France, Germany, Italy, United Kingdom, United States
• 2015-08-11

• Authorised

• The effect of bezafibrate on itch in a subset of liver diseases
• Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
• Netherlands
• 2015-07-20

• Authorised

• Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of additional surgery versus additional chemoradiotherapy after local excision for early rectal cancers.
• Patients with a margin free (at least 1 mm) endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm). According to current guidelines these patients require additional surgery after the local excision due to tumor characteristics;Therapeutic area: Diseases [C] - Cancer [C04]
• Netherlands
• 2015-07-09

• Authorised

• HBOT LYCA: exploring if pressurechamber treatment can reduce lymphoedema after breast cancer
• breast cancer related lymphedema;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
• Denmark
• 2015-03-10

• Authorised

• A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis.
• Relapsing-remitting multiple sclerosis already on interferon-beta therapy MedDRA version: 17.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
• United Kingdom
• 2015-01-19

• Authorised

• Panitumumab after Resection of Liver Metastases from Colorectal Cancer in RAS Wild-type Patients -PARLIM-
• Patients with metastatic colorectal cancer confined to the liver who underwent R0/1 resection of liver metastases MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
• Austria, Germany
• 2011-05-24

• Authorised

• Intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population
• All the patients from 1year to 18 years of age who have been diagnosed by a pediatric rheumatologist to have a joint inflammation needing intra-articular corticosteroid injection in 1 to 5 joints;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
• Finland
• 2016-11-02

• Authorised

• N/A
• Keskivaikeaa/vaikeaa atooppista ihottumaa sairastavat 1-3-vuotiaat lapset MedDRA version: 14.1 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
• Finland
• 2012-06-19

• Authorised

• EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE
• Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
• Italy
• 2012-03-14