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

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz,...

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;...

Riximyo is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Riximyo is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Riximyo …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Riximyo, rituximab, Lymphoma, Non-Hodgkin;Arthritis, Rheumatoid;...

Riximyo is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Riximyo is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Riximyo …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Orphan designation: tasimelteon, Treatment of non-24-hour sleep-wake disorders in blind people with no light perception, 23/02/...

On 23 February 2011, orphan designation (EU/3/10/841) was granted by the European Commission to Vanda Pharmaceuticals Limited, United Kingdom, for tasimelteon for the treatment of non-24-hour sleep-wake disorder in blind people with no light perception. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, ...

Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix. In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, ...

Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix. In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Skyrizi,Risankizumab, decision type: , therapeutic area: , PIP number: ...

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.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Empliciti, elotuzumab, Multiple Myeloma, Date of authorisation: 11/05/...

Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment. Empliciti is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Empliciti, elotuzumab, Multiple Myeloma, Date of authorisation: 11/05/...

Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow). It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment. Empliciti is …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Immunologic Deficiency Syndromes, ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): HyQvia, human normal immunoglobulin, Immunologic Deficiency Syndromes, ...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Muscular Atrophy, Spinal, Date of authorisation: ...

One main study, involving 121 babies (of an average age of 7 months) with SMA, showed that Spinraza is effective in improving movement when compared to placebo (sham injection). After one year of treatment, 51% of babies receiving Spinraza (37 out of 73) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Muscular Atrophy, Spinal, Date of authorisation: ...

One main study, involving 121 babies (of an average age of 7 months) with SMA, showed that Spinraza is effective in improving movement when compared to placebo (sham injection). After one year of treatment, 51% of babies receiving Spinraza (37 out of 73) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, Date of authorisation: ...

The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer. The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, Date of authorisation: ...

The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer. The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Carcinoma, Renal Cell, Date of authorisation: 25/08/...

The most common side effects of Kisplyx when used with pembrolizumab (which may affect more than 1 in 3 people) are diarrhoea, high blood pressure, tiredness, hypothyroidism (reduced thyroid-gland function), loss of appetite, nausea (feeling sick), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Carcinoma, Renal Cell, Date of authorisation: 25/08/...

The most common side effects of Kisplyx when used with pembrolizumab (which may affect more than 1 in 3 people) are diarrhoea, high blood pressure, tiredness, hypothyroidism (reduced thyroid-gland function), loss of appetite, nausea (feeling sick), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Advanced therapy medicinal products: Overview

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types: gene …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Clinical data publication

Clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified, in order to comply with European legislation on personal data protection. This usually involves redacting personal data …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Ceprotin, human protein C, Purpura Fulminans;Protein C Deficiency, Date ...

Ceprotin is a medicine used in patients with severe congenital protein C deficiency, a condition that increases the risk of blood clots. It is used to treat and prevent: purpura fulminans (extensive clotting of blood within the blood vessels, which causes …

Distribution channels: Healthcare & Pharmaceuticals Industry