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

Published on September 17, 2018 - 12:18 GMT

European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)

To obtain standardised data, participating countries provide their sales data of veterinary antimicrobials and animal population data based on a data reporting protocol and data collection form, which are available below. EMA processes the data according …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Trulicity,dulaglutide, 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.

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: ...

Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, Date of authorisation: ...

Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): 2009 - 2023

The annual ESVAC report presents data on the volume of sales of veterinary antimicrobial medicinal products collected from the 31 countries of the ESVAC network. It also highlights key changes and trends over time. Scientists, veterinarians and other …

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Published on September 17, 2018 - 12:18 GMT

International Coalition of Medicines Regulatory Authorities (ICMRA)

The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, …

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Published on September 17, 2018 - 12:18 GMT

Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - ...

The guideline defines acceptable data requirements for the demonstration of quality of veterinary medicinal products other than biologicals classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6. Keywords: availability, limited …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Liver Cirrhosis, Biliary, Date of ...

Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis. Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver. These ducts transport fluid called …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Ocaliva, obeticholic acid, Liver Cirrhosis, Biliary, Date of ...

Ocaliva is used to treat adults with a liver disease known as primary biliary cholangitis. Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the small bile ducts in the liver. These ducts transport fluid called …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Orkambi, lumacaftor,ivacaftor, Cystic Fibrosis, Date of authorisation: ...

Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system. It affects the cells that produce mucus and digestive juices. In …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Orkambi, lumacaftor,ivacaftor, Cystic Fibrosis, Date of authorisation: ...

Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above. Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system. It affects the cells that produce mucus and digestive juices. In …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia;Cancer, Date of authorisation: 22/...

Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections. It is given specifically to …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia;Cancer, Date of authorisation: 22/...

Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections. It is given specifically to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration;Macular Edema;Diabetes ...

Wet AMD Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD. The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Eylea, aflibercept, Wet Macular Degeneration;Macular Edema;Diabetes ...

Wet AMD Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD. The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three …

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Published on September 17, 2018 - 12:18 GMT

Worksharing: questions and answers

If the variations subject to worksharing affects the summary of product characteristics (SmPC), labelling or package leaflet, the revised product information annexes must be submitted as follows: a. Worksharing procedure for type-II variations At …

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Published on September 17, 2018 - 12:18 GMT

Orphan designation: Pomalidomide, Treatment of multiple myeloma, 08/10/2009, Expired

At the time of designation, multiple myeloma affected approximately 2.2 in 10,000 people in the European Union (EU). This was equivalent to a total of around 111,000 people*, and is below the threshold for orphan designation, which is 5 people in 10,000. …

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Published on September 17, 2018 - 12:18 GMT

Human medicines European public assessment report (EPAR): Colobreathe, colistimethate sodium, Cystic Fibrosis, Date of ...

This is a summary of the European public assessment report (EPAR) for Colobreathe. 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 - 12:18 GMT

Human medicines European public assessment report (EPAR): Colobreathe, colistimethate sodium, Cystic Fibrosis, Date of ...

This is a summary of the European public assessment report (EPAR) for Colobreathe. 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 - 12:18 GMT

Article 5(3) opinions on any scientific matter: human medicines

This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5(3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation …

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