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

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, Date of ...

The active substance in Pantozol Control, pantoprazole, is a proton-pump inhibitor. It works by blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Synjardy, empagliflozin,metformin, Diabetes Mellitus, Type 2, Date of ...

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Orphan designation: Sirolimus, Prevention of arteriovenous access dysfunction in haemodialysis patients, 13/11/2013, Positive

On 13 November 2013, orphan designation (EU/3/13/1204) was granted by the European Commission to S-Cubed Limited, United Kingdom, for sirolimus for the prevention of arteriovenous access dysfunction in patients undergoing surgical creation of an …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Synjardy, empagliflozin,metformin, Diabetes Mellitus, Type 2, Date of ...

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Simponi, golimumab, Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis,...

Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Simponi, golimumab, Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis,...

Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ...

On 29 July 2014, orphan designation (EU/3/14/1298) was granted by the European Commission to Alnylam UK Limited, United Kingdom, for synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand …

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Published on September 17, 2018 - 12:28 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Tofacitinib, decision type: , therapeutic area: , PIP number: P/0055/...

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 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation;Reproductive Techniques, ...

Ovitrelle is a medicine used in women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of an egg from the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy. It …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ovitrelle, choriogonadotropin alfa, Anovulation;Reproductive Techniques, ...

Ovitrelle is a medicine used in women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of an egg from the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy. It …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary,...

Adults Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Imbruvica, ibrutinib, Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, ...

Chronic lymphocytic leukaemia In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly), tadalafil, Hypertension, Pulmonary,...

Adults Treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, Date of authorisation: 09/11/...

Ritonavir Mylan can only be obtained with a prescription and treatment with Ritonavir Mylan should be given by a doctor who has experience in the treatment of HIV infection. It is available as tablets (100 mg) and should be taken with food. Ritonavir Mylan …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, Date of authorisation: 09/11/...

Ritonavir Mylan can only be obtained with a prescription and treatment with Ritonavir Mylan should be given by a doctor who has experience in the treatment of HIV infection. It is available as tablets (100 mg) and should be taken with food. Ritonavir Mylan …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Imbruvica, ibrutinib, Lymphoma, Mantle-Cell;Leukemia, Lymphocytic, ...

Chronic lymphocytic leukaemia In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Orphan designation: Cannabidiol, Treatment of Dravet syndrome, 15/10/2014, Positive

On 15 October 2014, orphan designation (EU/3/14/1339) was granted by the European Commission to GW Pharma Ltd, United Kingdom, for cannabidiol for the treatment of Dravet syndrome. Cannabidiol treatment of Dravet syndrome and treatment of Lennox-Gastaut …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, ...

Vials Menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, ...

Vials Menveo is indicated for active immunisation of children (from two years of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease. The use of this vaccine should be in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia;Diabetic Neuropathies;Depressive ...

Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being …

Distribution channels: Healthcare & Pharmaceuticals Industry