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

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Neuraceq, florbetaben (18F), Radionuclide Imaging;Alzheimer Disease, ...

This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of β amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq,Upadacitinib (ABT-494), 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 - 12:31 GMT

Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, Date of authorisation: 18/02/2016, ...

Hypersensitivity (allergic) reactions are uncommon with Kovaltry, affecting from 1 patient in 1,000 to less than 1 patient in 100. If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-Small-...

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-Small-...

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Kovaltry, octocog alfa, Hemophilia A, Date of authorisation: 18/02/2016, ...

Hypersensitivity (allergic) reactions are uncommon with Kovaltry, affecting from 1 patient in 1,000 to less than 1 patient in 100. If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime,avibactam, Pneumonia, Bacterial;Soft Tissue ...

The benefits of Zavicefta have been shown in five main studies in adults. In two studies, the combination of Zavicefta and metronidazole (another antibiotic) was at least as effective as the antibiotic meropenem in 1,490 patients with complicated intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Orencia, abatacept, Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;...

Rheumatoid arthritis Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis. The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Vosevi, sofosbuvir,velpatasvir,voxilaprevi, Hepatitis C, Chronic, Date ...

Vosevi has been shown in four main studies of 1,459 adults to be effective at clearing all six varieties (genotypes) of HCV, including in patients with liver cirrhosis and those who have previously tried other direct-acting antivirals. The clearance rates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Orencia, abatacept, Arthritis, Psoriatic;Arthritis, Juvenile Rheumatoid;...

Rheumatoid arthritis Four main studies involving a total of 1,733 adults found Orencia effective in rheumatoid arthritis. The main measures of effectiveness were the reduction in symptoms of arthritis after treatment, as well as physical function (the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime,avibactam, Pneumonia, Bacterial;Soft Tissue ...

The benefits of Zavicefta have been shown in five main studies in adults. In two studies, the combination of Zavicefta and metronidazole (another antibiotic) was at least as effective as the antibiotic meropenem in 1,490 patients with complicated intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:31 GMT

Edison Nation to Host Corporate Update Webinar Today, Monday, September 17th at 4:30 p.m. Eastern Time

PHILLIPSBURG, N.J., Sept. 17, 2018 (GLOBE NEWSWIRE) -- Edison Nation, Inc. (“Edison” or the “Company”), a full-service product development company, will host a virtual webinar today, Monday, September 17, 2018 at 4:30 p.m. Eastern time (1:30 p.m. Pacific …

Distribution channels:

Published on September 17, 2018 - 12:31 GMT

Human medicines European public assessment report (EPAR): Vosevi, sofosbuvir,velpatasvir,voxilaprevi, Hepatitis C, Chronic, Date ...

Vosevi has been shown in four main studies of 1,459 adults to be effective at clearing all six varieties (genotypes) of HCV, including in patients with liver cirrhosis and those who have previously tried other direct-acting antivirals. The clearance rates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Aubagio, teriflunomide, Multiple Sclerosis, Date of authorisation: 26/08/...

Aubagio has been studied in five main studies involving over 2,900 patients with relapsing-remitting MS. One study involving 179 adults compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Trimbow, beclometasone,formoterol,glycopyrronium bromide, Pulmonary ...

COPD Trimbow has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a long-acting muscarinic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Aubagio, teriflunomide, Multiple Sclerosis, Date of authorisation: 26/08/...

Aubagio has been studied in five main studies involving over 2,900 patients with relapsing-remitting MS. One study involving 179 adults compared the effects of Aubagio with placebo (a dummy treatment) on the number of active lesions (developing areas of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Orphan designation: Pegunigalsidase alfa, Treatment of Fabry disease, 12/12/2017, Withdrawn

Fabry disease is an inherited disease that is caused by the lack of an enzyme called alpha galactosidase A, which breaks down and removes Gb3, a complex molecule containing sugars and fats. In patients with this condition, large amounts of Gb3 build up in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Trimbow, beclometasone,formoterol,glycopyrronium bromide, Pulmonary ...

COPD Trimbow has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a long-acting muscarinic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, Date of authorisation: 22/05/...

Treatment of influenza In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:30 GMT

Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, Date of authorisation: 22/05/...

Treatment of influenza In patients one year of age and older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Ebilfumin is indicated for the treatment of infants less than 1 year of age during a pandemic …

Distribution channels: Healthcare & Pharmaceuticals Industry