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

Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, Date of ...

Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to …

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Published on September 17, 2018 - 12:29 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Mekinist,Trametinib (dimethyl sulfoxide), decision type: , therapeutic ...

Invented name Active substance Trametinib (dimethyl sulfoxide) Therapeutic area Decision number PIP number Pharmaceutical form(s) Condition(s) / indication(s) Treatment of all conditions included in the category of malignant neoplasms (except melanoma, …

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Published on September 17, 2018 - 12:29 GMT

Orphan designation: edaravone, Treatment of amyotrophic lateral sclerosis, 19/06/2015, Positive

On 19 June 2015, orphan designation (EU/3/15/1510) was granted by the European Commission to Mitsubishi Tanabe Pharma Europe Ltd, United Kingdom, for edaravone for the treatment of amyotrophic lateral sclerosis. The sponsorship was transferred to …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, Date of authorisation: 08/07/1999, ...

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, Date of authorisation: 08/07/1999, ...

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with …

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Published on September 17, 2018 - 12:29 GMT

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

Epclusa is an antiviral medicine used to treat patients from 3 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus. Hepatitis C virus occurs in several varieties (genotypes), and …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, Date of ...

Treatment with Lamivudine Teva Pharma B.V. should be initiated by a doctor who has experience in the management of HIV infection. The recommended dose of Lamivudine Teva Pharma B.V. for adults and children weighing at least 25 kg is 300 mg a day. This can …

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Published on September 17, 2018 - 12:29 GMT

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

Epclusa is an antiviral medicine used to treat patients from 3 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus. Hepatitis C virus occurs in several varieties (genotypes), and …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Ovarian Neoplasms, Date of authorisation: 16/12/2014,...

Ovarian cancer Studies show that Lynparza given on its own increases the time women with cancer of the ovary, fallopian tube or peritoneum live without their disease getting worse after treatment with platinum-based chemotherapy has shrunk or cleared the …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Lynparza, olaparib, Ovarian Neoplasms, Date of authorisation: 16/12/2014,...

Ovarian cancer Studies show that Lynparza given on its own increases the time women with cancer of the ovary, fallopian tube or peritoneum live without their disease getting worse after treatment with platinum-based chemotherapy has shrunk or cleared the …

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Published on September 17, 2018 - 12:29 GMT

Orphan designation: 5'-ASCSASTSCSASGSTSCSTSGSASUSASASGSCSTSA-3' (lademirsen), Treatment of Alport syndrome, 19/03/2015, Withdrawn

At the time of designation, Alport syndrome affected not more than 2 in 10,000 people in the European Union (EU). This was equivalent to a total of not more than 103,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Heart Failure, Date of authorisation: 26/...

Neparvis is a heart medicine used in adults with chronic (long-term) heart failure who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). The medicine is also used in adolescents and children from 1 …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Neparvis, sacubitril,valsartan, Heart Failure, Date of authorisation: 26/...

Neparvis is a heart medicine used in adults with chronic (long-term) heart failure who have symptoms of the disease and reduced ejection fraction (a measure of how well the heart pumps blood). The medicine is also used in adolescents and children from 1 …

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Published on September 17, 2018 - 12:29 GMT

Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen, 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.

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Anemia;Kidney Failure,...

Adults Mircera was shown to be as effective as the comparator medicines in correcting and maintaining haemoglobin levels in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease. Mircera was compared with …

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Published on September 17, 2018 - 12:29 GMT

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Anemia;Kidney Failure,...

Adults Mircera was shown to be as effective as the comparator medicines in correcting and maintaining haemoglobin levels in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease. Mircera was compared with …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, Date of ...

The active substance in Pantozol Control, pantoprazole, is a proton-pump inhibitor. It works by blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, Date of ...

The active substance in Pantozol Control, pantoprazole, is a proton-pump inhibitor. It works by blocking ‘proton pumps’, proteins found in specialised cells in the stomach lining that pump acid into the stomach. By blocking the pumps, pantoprazole reduces …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Synjardy, empagliflozin,metformin, Diabetes Mellitus, Type 2, Date of ...

The benefits of empagliflozin in combination with metformin have been shown in 3 main studies involving 1,679 patients with type 2 diabetes whose blood sugar was not adequately controlled by metformin, alone or combined with other diabetes medicines (such …

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Published on September 17, 2018 - 12:28 GMT

Orphan designation: Sirolimus, Prevention of arteriovenous access dysfunction in haemodialysis patients, 13/11/2013, Positive

On 13 November 2013, orphan designation (EU/3/13/1204) was granted by the European Commission to S-Cubed Limited, United Kingdom, for sirolimus for the prevention of arteriovenous access dysfunction in patients undergoing surgical creation of an …

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