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

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, Date of authorisation: 11/...

Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, Date of authorisation: 11/...

Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene, Treatment of ...

On 26 March 2014, orphan designation (EU/3/14/1257) was granted by the European Commission to Prof F.J.T. Staal, the Netherlands, for autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene for the treatment of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, Date of authorisation:...

Most of the side effects with Alli affect the digestive system and are less likely to occur with a low fat diet. In general, they are mild, and occur at the beginning of treatment, going away after some time. The most common side effects with Alli (seen in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, Date of authorisation:...

Most of the side effects with Alli affect the digestive system and are less likely to occur with a low fat diet. In general, they are mild, and occur at the beginning of treatment, going away after some time. The most common side effects with Alli (seen in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic;Arthritis, Rheumatoid;...

Rheumatoid arthritis Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic;Arthritis, Rheumatoid;...

Rheumatoid arthritis Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), ...

Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with …

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Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), ...

Sevelamer carbonate Winthrop is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:27 GMT

Orphan designation: Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene, ...

At the time of designation, neuronal ceroid lipofuscinosis affected approximately 0.3 in 10,000 people in the European Union (EU). This was equivalent to a total of around 15,000 people*, and is below the ceiling for orphan designation, which is 5 people …

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Published on September 17, 2018 - 12:27 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Pifeltro,doravirine, 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 - 12:27 GMT

Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders;Autistic ...

The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available. Slenyto has been shown to improve sleeping times in these …

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Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders;Autistic ...

The proportion of children with neurological conditions, such as autism spectrum disorder (ASD) and Smith-Magenis syndrome, who also have insomnia is high and not many treatments are available. Slenyto has been shown to improve sleeping times in these …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) ...

Twinrix Adult is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen’ (proteins from …

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Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) ...

Twinrix Adult is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Twinrix Adult contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen’ (proteins from …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine,valsartan,hydrochlorothiazide, Hypertension, ...

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine,valsartan,hydrochlorothiazide, Hypertension, ...

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia;Alzheimer Disease;Parkinson Disease, Date ...

Treatment with Exelon should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease or dementia in patients with Parkinson’s disease. Treatment should only be started if a caregiver is available who …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Exelon, rivastigmine, Dementia;Alzheimer Disease;Parkinson Disease, Date ...

Treatment with Exelon should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease or dementia in patients with Parkinson’s disease. Treatment should only be started if a caregiver is available who …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:26 GMT

Human medicines European public assessment report (EPAR): Tegsedi, inotersen, Amyloidosis, Date of authorisation: 06/07/2018, ...

Tegsedi is a medicine used to treat nerve damage caused by hereditary transthyretin amyloidosis (hATTR), a disease in which proteins called amyloids build up in tissues around the body including around the nerves. Tegsedi is used in adult patients in the …

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