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

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide, Hepatitis B, Date of authorisation: 09/...

Vemlidy reduces levels of hepatitis B virus in most patients. In a study of 426 patients with ‘e-antigen negative’ chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment. This result was similar to that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide, Hepatitis B, Date of authorisation: 09/...

Vemlidy reduces levels of hepatitis B virus in most patients. In a study of 426 patients with ‘e-antigen negative’ chronic hepatitis, 94% of patients on Vemlidy had very low levels of viral DNA after 48 weeks of treatment. This result was similar to that …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

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

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 - 12:21 GMT

Human medicines European public assessment report (EPAR): Jinarc, tolvaptan, Polycystic Kidney, Autosomal Dominant, Date of ...

The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day). Jinarc may …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Jinarc, tolvaptan, Polycystic Kidney, Autosomal Dominant, Date of ...

The most common side effects with Jinarc (which may affect more than 2 in 10 people) are thirst, polyuria (increase in urine production), nocturia (need to pass urine at night) and pollakiuria (increased need to pass urine during the day). Jinarc may …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Availability of veterinary vaccines

In February 2016, HMA and EMA established a joint steering group to strategically oversee the plan's implementation. Members include senior regulators from the network, with the EC and European Directorate for the Quality of Medicines and HealthCare ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Lixiana, edoxaban, Stroke;Venous Thromboembolism, Date of authorisation: ...

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Lixiana, edoxaban, Stroke;Venous Thromboembolism, Date of authorisation: ...

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Omidria, phenylephrine,ketorolac, Lens Implantation, Intraocular;Pain, ...

Omidria has been investigated in two main studies involving a total of 821 patients undergoing lens replacement surgery, in which it was compared with placebo (a dummy treatment). In both studies, the main measures of effectiveness were the change in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

Human medicines European public assessment report (EPAR): Omidria, phenylephrine,ketorolac, Lens Implantation, Intraocular;Pain, ...

Omidria has been investigated in two main studies involving a total of 821 patients undergoing lens replacement surgery, in which it was compared with placebo (a dummy treatment). In both studies, the main measures of effectiveness were the change in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:21 GMT

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

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 - 12:21 GMT

How to prepare and review a summary of product characteristics

This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Osisko Metals Intersects 20.48% Zinc+Lead Over 6.23 Metres at Pine Point

MONTREAL, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Osisko Metals Incorporated (the “Company” or “Osisko Metals”) (TSX-V: OM; FRANKFURT: OB51) is pleased to announce assay results from 7 near-surface drill holes completed in the East Mill Zone at the Pine Point …

Distribution channels: Mining Industry ...

Published on September 17, 2018 - 12:20 GMT

Annual reports and work programmes

The European Medicines Agency (EMA) publishes a full work programme and annual report, to provide an overview of the work of the Agency together with the European medicines regulatory network. 2022 annual report (updated) Update: EMA's 2022 annual …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, Date of ...

The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Palivizumab has been designed to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, Date of ...

The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Palivizumab has been designed to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Fees payable to the European Medicines Agency

The Agency charges fees for applications for marketing authorisation, and for variations and other changes to marketing authorisations, as well as annual fees for authorised medicines. Examples of current basic fees Fee type Human medicines Veterinary …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Zejula, niraparib, Fallopian Tube Neoplasms;Peritoneal Neoplasms;Ovarian ...

Zejula is a cancer medicine used in women with advanced ovarian cancer, which includes cancer of the ovaries, fallopian tubes (that connect the ovaries to the uterus) or the peritoneum (the lining around the abdomen). It can be used on its own for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Zejula, niraparib, Fallopian Tube Neoplasms;Peritoneal Neoplasms;Ovarian ...

Zejula is a cancer medicine used in women with advanced ovarian cancer, which includes cancer of the ovaries, fallopian tubes (that connect the ovaries to the uterus) or the peritoneum (the lining around the abdomen). It can be used on its own for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia;Bipolar Disorder, Date of ...

Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the …

Distribution channels: Healthcare & Pharmaceuticals Industry