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

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, Date of authorisation: 25/...

Levetiracetam Teva is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, Date of authorisation: 25/...

Levetiracetam Teva is an epilepsy medicine. It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation. This is a type of epilepsy where too much …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Halaven, eribulin, Breast Neoplasms;Liposarcoma, Date of authorisation: ...

Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an …

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Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Halaven, eribulin, Breast Neoplasms;Liposarcoma, Date of authorisation: ...

Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimens for advanced disease (see section 5.1). Prior therapy should have included an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Thyroid Neoplasms, Date of authorisation: 28/05/...

The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Lenvima, lenvatinib, Thyroid Neoplasms, Date of authorisation: 28/05/...

The most common side effects with Lenvima (which may affect more than 3 in 10 people) are hypertension (high blood pressure), diarrhoea, decreased appetite and weight, tiredness, nausea (feeling sick), proteinuria (protein in the urine), stomatitis ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

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

Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. is also indicated for the treatment of HIV-1 infected adolescents, with …

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Published on September 17, 2018 - 12:24 GMT

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

Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. is also indicated for the treatment of HIV-1 infected adolescents, with …

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Published on September 17, 2018 - 12:24 GMT

Orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles, Treatment ...

Please note that this product was withdrawn from the Union Register of orphan medicinal products in June 2023 on request of the Sponsor. On 25 May 2018, orphan designation (EU/3/18/2025) was granted by the European Commission to Pharma Gateway AB, Sweden, …

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Published on September 17, 2018 - 12:24 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Trajenta,linagliptin, 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 - 12:24 GMT

Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, ...

The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles’), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:24 GMT

Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, ...

The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles’), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Mirapexin, pramipexole, Restless Legs Syndrome;Parkinson Disease, Date ...

Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Mirapexin, pramipexole, Restless Legs Syndrome;Parkinson Disease, Date ...

Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Desloratadine Actavis, desloratadine, Rhinitis, Allergic, Perennial;...

The active substance in Desloratadine Actavis, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Desloratadine Actavis, desloratadine, Rhinitis, Allergic, Perennial;...

The active substance in Desloratadine Actavis, desloratadine, is an antihistamine. It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself. When the receptors are blocked, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Entresto,sacubitril,valsartan, decision type: , therapeutic area: , PIP ...

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 - 12:23 GMT

Human medicines European public assessment report (EPAR): Ovaleap, follitropin alfa, Anovulation, Date of authorisation: 27/09/...

The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Human medicines European public assessment report (EPAR): Ovaleap, follitropin alfa, Anovulation, Date of authorisation: 27/09/...

The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:23 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Cometriq,cabozantinib, 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