Press Releases on September 17, 2018 - EIN Presswire - Press Release Distribution Service

Published on September 17, 2018 - 12:23 GMT

Orphan designation: Cannabidivarin, Treatment of fragile X syndrome, 22/02/2018, Positive

Fragile X syndrome is an inherited disease characterised by learning disability. Other symptoms include difficulty communicating and socialising, anxiety, hyperactivity (restlessness), and repetitive and stereotyped behaviours. The disease is caused by a …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke;Peripheral Vascular Diseases;Atrial ...

Iscover was more effective than acetylsalicylic acid at preventing new ischaemic events. In a study in around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease, 939 patients who …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Iscover, clopidogrel, Stroke;Peripheral Vascular Diseases;Atrial ...

Iscover was more effective than acetylsalicylic acid at preventing new ischaemic events. In a study in around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease, 939 patients who …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Fotivda, tivozanib hydrochloride monohydrate, Carcinoma, Renal Cell, ...

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Fotivda, tivozanib hydrochloride monohydrate, Carcinoma, Renal Cell, ...

Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Rydapt, midostaurin, Leukemia, Myeloid, Acute;Mastocytosis, Date of ...

When used to treat AML, the most common side effects with Rydapt (which may affect more than 1 in 10 people) are febrile neutropenia (fever and low white blood cell count, seen in nearly all patients), exfoliative dermatitis (inflamed, peeling skin), …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Busilvex, busulfan, Hematopoietic Stem Cell Transplantation, Date of ...

Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Busilvex, busulfan, Hematopoietic Stem Cell Transplantation, Date of ...

Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option. Busilvex …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-...

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node- …

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Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-...

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node- …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, Date of ...

For CLL, the most common side effects with Venclyxto used with obinutuzumab or rituximab or on its own (seen in more than 1 in 10 people) are pneumonia (lung infection), nose and throat infection, low levels of neutrophils (a type of white blood cell), …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Venclyxto, venetoclax, Leukemia, Lymphocytic, Chronic, B-Cell, Date of ...

For CLL, the most common side effects with Venclyxto used with obinutuzumab or rituximab or on its own (seen in more than 1 in 10 people) are pneumonia (lung infection), nose and throat infection, low levels of neutrophils (a type of white blood cell), …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Mozobil, plerixafor, Multiple Myeloma;Hematopoietic Stem Cell ...

Mozobil is a medicine used to mobilise blood stem cells from a patient’s bone marrow so that they can be collected and used later for transplantation in the same patient. Mozobil is used together with the hormone granulocyte-colony stimulating factor (G- …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Mozobil, plerixafor, Multiple Myeloma;Hematopoietic Stem Cell ...

Mozobil is a medicine used to mobilise blood stem cells from a patient’s bone marrow so that they can be collected and used later for transplantation in the same patient. Mozobil is used together with the hormone granulocyte-colony stimulating factor (G- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Rydapt, midostaurin, Leukemia, Myeloid, Acute;Mastocytosis, Date of ...

When used to treat AML, the most common side effects with Rydapt (which may affect more than 1 in 10 people) are febrile neutropenia (fever and low white blood cell count, seen in nearly all patients), exfoliative dermatitis (inflamed, peeling skin), …

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Published on September 17, 2018 - 12:22 GMT

Orphan designation: 4,7,10,13,16,19-docosahexaenoic acid, Treatment of retinitis pigmentosa, 04/11/2006, Positive

On 3 November 2006, orphan designation (EU/3/06/412) was granted by the European Commission to Jose Manuel Cela Lopez, Spain, for 4,7,10,13,16,19-docosahexaenoic acid for the treatment of retinitis pigmentosa. The sponsorship was transferred to Celavista …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Anxiety Disorders;Neuralgia;Epilepsy, ...

Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. …

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Pregabalin Sandoz, pregabalin, Anxiety Disorders;Neuralgia;Epilepsy, ...

Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. …

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Published on September 17, 2018 - 12:22 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/...

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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Published on September 17, 2018 - 12:22 GMT

Human medicines European public assessment report (EPAR): Cyramza, ramucirumab, Stomach Neoplasms, Date of authorisation: 19/12/...

Cyramza was found effective in patients with advanced gastric or gastro-oesophageal junction cancer, metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer and hepatocellular carcinoma in 6 main studies. Gastric cancer In one main …

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