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

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Arixtra, fondaparinux sodium, Venous Thrombosis;Pulmonary Embolism;...

1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Kyntheum,brodalumab, 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 - 12:20 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

Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris,ravulizumab, 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 - 12:20 GMT

Opinion/decision on a Paediatric investigation plan (PIP): magnesium sulfate heptahydrate (BLI800),Sodium sulphate anhydrou,...

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 - 12:20 GMT

Human medicines European public assessment report (EPAR): Evotaz, atazanavir,cobicistat, HIV Infections, Date of authorisation: 13/...

Because atazanavir and cobicistat have both previously been shown to be effective and are authorised for use in the treatment of HIV-1 infection, studies were mainly carried out to show that Evotaz produced levels of atazanavir in the blood similar to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Frequently asked questions about parallel distribution

The Agency fulfils its obligation to check the conditions of parallel distribution by means of five procedures. Initial Notification An initial notification is a parallel distributor’s notification to the Agency, informing of their intent to source, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate,umeclidinium,vilanterol, Pulmonary ...

Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate,umeclidinium,vilanterol, Pulmonary ...

Elebrato Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Network Portfolio

The Network Portfolio is the collective term for information technology (IT) systems and services managed by the European Medicines Agency (EMA). These may be under development or in production and use by the European medicines regulatory network, EMA' …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Vimizim, elosulfase alfa, Mucopolysaccharidosis IV, Date of ...

Vimizim is a medicine that contains the active substance elosulfase alfa. It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome). This disease is caused by the lack of an enzyme called N- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Vimizim, elosulfase alfa, Mucopolysaccharidosis IV, Date of ...

Vimizim is a medicine that contains the active substance elosulfase alfa. It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome). This disease is caused by the lack of an enzyme called N- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Good clinical practice

1. EMA-FDA GCP initiative The Agency and the United States Food and Drug Administration (FDA) agreed to launch a joint initiative to collaborate on international GCP inspection activities in July 2009. The initiative forms an important contribution to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Instanyl, fentanyl, Pain;Cancer, Date of authorisation: 20/07/2009, ...

Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients. The doctor should keep in mind the Instanyl is available as a nasal spray (50, 100 and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): Instanyl, fentanyl, Pain;Cancer, Date of authorisation: 20/07/2009, ...

Treatment with Instanyl should be started by and remain under the supervision of a doctor who has experience in the management of opioid treatment in cancer patients. The doctor should keep in mind the Instanyl is available as a nasal spray (50, 100 and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Orphan designation: Rifapentine, Treatment of tuberculosis, 09/06/2010, Positive

On 9 June 2010, orphan designation (EU/3/10/750) was granted by the European Commission to Sanofi-Aventis, France, for rifapentine for the treatment of tuberculosis. For a list of the administrative updates to this public summary of opinion, please refer …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Human medicines European public assessment report (EPAR): INOmax, nitric oxide, Hypertension, Pulmonary;Respiratory Insufficiency, ...

This is a summary of the European public assessment report (EPAR) for INOmax. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Implementation of the pharmacovigilance legislation

Risk-management plans The pharmacovigilance legislation strengthened procedures concerning risk-management plans. This includes requiring a risk-management plan for all new medicines and the publication of summaries of risk-management plans, which the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:20 GMT

Diana Shipping Inc. Announces Time Charter Contract for m/v Artemis With Ausca

ATHENS, Greece, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Diana Shipping Inc. (NYSE:DSX), (the “Company”), a global shipping company specializing in the ownership of dry bulk vessels, today announced that, through a separate wholly-owned subsidiary, it has …

Distribution channels: Business & Economy, Shipping, Storage & Logistics ...