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

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Psoriasis;Arthritis, Psoriatic;Crohn Disease;...

Plaque psoriasis In the treatment of moderate to severe plaque psoriasis, Stelara was more effective than placebo (a dummy treatment) in 2 main studies involving a total of 1,996 adult patients. In over half of these patients, other treatments for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Stelara, ustekinumab, Psoriasis;Arthritis, Psoriatic;Crohn Disease;...

Plaque psoriasis In the treatment of moderate to severe plaque psoriasis, Stelara was more effective than placebo (a dummy treatment) in 2 main studies involving a total of 1,996 adult patients. In over half of these patients, other treatments for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Training and resources for patients and consumers

Members of EMA's eligible organisation also have training initiatives that promote a better understanding of the development and approval of medicines as well as the involvement of patients and consumers in these processes. While EMA takes care in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Pergoveris, follitropin alfa,lutropin alfa, Infertility, Female, Date of ...

This is a summary of the European public assessment report (EPAR) for Pergoveris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Pergoveris, follitropin alfa,lutropin alfa, Infertility, Female, Date of ...

This is a summary of the European public assessment report (EPAR) for Pergoveris. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Advisory functions

The European Medicines Agency has advisory functions and support services that support the Executive Director and the Agency on a range of operational, policy and scientific issues in their various fields of expertise. The advisory functions report …

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Published on September 17, 2018 - 12:17 GMT

Orphan designation: Imetelstat sodium, Treatment of myelofibrosis, 14/12/2015, Positive

On 14 December 2015, orphan designation (EU/3/15/1593) was granted by the European Commission to Janssen-Cilag International N.V., Belgium, for imetelstat sodium for the treatment of myelofibrosis. The sponsorship was transferred to Parexel International …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell;Carcinoma, Non-...

Urothelial cancer Tecentriq reduces tumours in patients with urothelial cancer that is advanced or has spread. In a study of 429 patients, the cancer shrank or was eliminated after Tecentriq treatment in 23% of patients who were not eligible for platinum …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Carcinoma, Transitional Cell;Carcinoma, Non-...

Urothelial cancer Tecentriq reduces tumours in patients with urothelial cancer that is advanced or has spread. In a study of 429 patients, the cancer shrank or was eliminated after Tecentriq treatment in 23% of patients who were not eligible for platinum …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Somavert, pegvisomant, Acromegaly, Date of authorisation: 12/11/2002, ...

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. …

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Published on September 17, 2018 - 12:17 GMT

Extensions of marketing authorisations: questions and answers

In case the Extension Application requires changes to the product information (e.g. new strength or pharmaceutical form), the same requirements as for a new application apply: At submission and during assessment, only the English language clean and …

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Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Brintellix, vortioxetine, Depressive Disorder, Major, Date of ...

Brintellix has been studied in 12 main short-term studies involving more than 6,700 patients with major depression (including one study in patients aged 65 and over), in which it was compared with placebo (a dummy treatment) for 6 or 8 weeks. The main …

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Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Brintellix, vortioxetine, Depressive Disorder, Major, Date of ...

Brintellix has been studied in 12 main short-term studies involving more than 6,700 patients with major depression (including one study in patients aged 65 and over), in which it was compared with placebo (a dummy treatment) for 6 or 8 weeks. The main …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate,umeclidinium,vilanterol, Pulmonary ...

Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Trelegy Ellipta, fluticasone furoate,umeclidinium,vilanterol, Pulmonary ...

Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Human medicines European public assessment report (EPAR): Somavert, pegvisomant, Acromegaly, Date of authorisation: 12/11/2002, ...

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

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

At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur. These side effects are very common but disappear on their own in most cases. Lactic acidosis (a build-up of lactic acid in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

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

At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur. These side effects are very common but disappear on their own in most cases. Lactic acidosis (a build-up of lactic acid in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:17 GMT

Orphan designation: everolimus, Treatment of tuberous sclerosis, 04/08/2010, Expired

The effects of everolimus have been evaluated in experimental models. At the time of submission of the application for orphan designation, clinical trials with everolimus in patients with tuberous sclerosis were ongoing. Everolimus was first authorised for …

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Published on September 17, 2018 - 12:17 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, decision type: , therapeutic area: , PIP number: P/0400/...

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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