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

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

Published on September 17, 2018 - 12:09 GMT

Pharmaceutical industry

The pharmaceutical industry and medical device industry associations in the European Union (EU) are some of the European Medicines Agency's (EMA) main stakeholders. Interacting with pharmaceutical companies has been a major part of EMA's daily …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Rebetol, ribavirin, Hepatitis C, Chronic, Date of authorisation: 06/05/...

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric …

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Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Rebetol, ribavirin, Hepatitis C, Chronic, Date of authorisation: 06/05/...

Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric …

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Published on September 17, 2018 - 12:09 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human monoclonal antibody to GM-CSF (GSK3196165), decision ...

Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylarthritis and juvenile idiopathic arthritis)

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Published on September 17, 2018 - 12:09 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Juluca,rilpivirine,dolutegravir, decision type: , therapeutic area: , ...

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 - 12:09 GMT

Orphan designation: Cannabidiol, Treatment of perinatal asphyxia, 28/07/2015, Positive

At the time of designation, perinatal asphyxia affected less than 1 in 10,000 people in the European Union (EU). This was equivalent to a total of fewer than 51,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. This …

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Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing;Arthritis, Juvenile ...

Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing;Arthritis, Juvenile ...

Rheumatoid arthritis Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Breast Neoplasms, Date of authorisation: 22/08/2017,...

Kisqali is a cancer medicine used to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It can only be used when the cancer cells have receptors (targets) for certain sex hormones on …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Breast Neoplasms, Date of authorisation: 22/08/2017,...

Kisqali is a cancer medicine used to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It can only be used when the cancer cells have receptors (targets) for certain sex hormones on …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine,tenofovir ...

Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 …

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Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka, emtricitabine,tenofovir ...

Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 …

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Published on September 17, 2018 - 12:09 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Reblozyl,Luspatercept, 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 - 12:09 GMT

Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis;Keratosis, Actinic, Date of authorisation: ...

Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are …

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Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis;Keratosis, Actinic, Date of authorisation: ...

Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Sprycel, dasatinib (anhydrous), Precursor Cell Lymphoblastic Leukemia-...

The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working. None of these studies compared Sprycel with another medicine. Most of these studies assessed …

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Published on September 17, 2018 - 12:09 GMT

Human medicines European public assessment report (EPAR): Sprycel, dasatinib (anhydrous), Precursor Cell Lymphoblastic Leukemia-...

The five main studies of Sprycel in adults involved 515 patients, all of whom had received treatment with imatinib, which had not worked or had stopped working. None of these studies compared Sprycel with another medicine. Most of these studies assessed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:08 GMT

Human medicines European public assessment report (EPAR): Maviret, glecaprevir,pibrentasvir, Hepatitis C, Chronic, Date of ...

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older. Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:08 GMT

Human medicines European public assessment report (EPAR): Maviret, glecaprevir,pibrentasvir, Hepatitis C, Chronic, Date of ...

Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older. Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and …

Distribution channels: Healthcare & Pharmaceuticals Industry