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

Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, Date of authorisation: 09/11/...

Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, Date of authorisation: 09/11/...

Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Orphan designation: Cyclic pyranopterin monophosphate (fosdenopterin), Treatment of molybdenum-cofactor deficiency type A, 20/09/...

On 20 September 2010, orphan designation (EU/3/10/777) was granted by the European Commission to Orphatec Pharmaceuticals GmbH, Germany, for cyclic pyranopterin monophosphate for the treatment of molybdenum-cofactor deficiency type A. This medicine is now …

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Published on September 17, 2018 - 12:26 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Rxulti,brexpiprazole, 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 - 12:25 GMT

Human medicines European public assessment report (EPAR): Viramune, nevirapine, HIV Infections, Date of authorisation: 04/02/1998, ...

Tablets and oral suspension Viramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age. Most of the experience with Viramune is in combination with …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, Date of authorisation: 31/08/2018, ...

Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery. It is given following treatment with trastuzumab (another medicine used for the same purpose). It is intended …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Nerlynx, neratinib, Breast Neoplasms, Date of authorisation: 31/08/2018, ...

Nerlynx is a breast cancer medicine used to reduce the risk of the disease coming back in patients with early breast cancer who have had surgery. It is given following treatment with trastuzumab (another medicine used for the same purpose). It is intended …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Lojuxta, lomitapide, Hypercholesterolemia, Date of authorisation: 31/07/...

Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;...

Melanoma (skin cancer) Keytruda can delay worsening of melanoma and improve survival. Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Lojuxta, lomitapide, Hypercholesterolemia, Date of authorisation: 31/07/...

Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH). Genetic confirmation of HoFH …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Gefitinib Mylan, gefitinib, Carcinoma, Non-Small-Cell Lung, Date of ...

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan. As for every medicine, the company provided studies on …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Gefitinib Mylan, gefitinib, Carcinoma, Non-Small-Cell Lung, Date of ...

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan. As for every medicine, the company provided studies on …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Keytruda, pembrolizumab, Melanoma;Hodgkin Disease;Carcinoma, Renal Cell;...

Melanoma (skin cancer) Keytruda can delay worsening of melanoma and improve survival. Results from a study of 540 previously treated patients with melanoma showed that 2 years after start of treatment, the disease had not worsened in 16% of patients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Mayzent,Siponimod (hemifumarate), decision type: , therapeutic area: , ...

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 - 12:25 GMT

Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, Date of ...

The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST-segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Rapiscan, regadenoson, Myocardial Perfusion Imaging, Date of ...

The most common side effects with Rapiscan (seen in more than 1 patient in 10) are headache, dizziness, ST-segment changes (an abnormal reading on the electrocardiogram or ECG), flushing (reddening of the skin), dyspnoea (difficulty breathing), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Amyloidosis, Familial, Date of authorisation: 27/08/...

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

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Onpattro, patisiran, Amyloidosis, Familial, Date of authorisation: 27/08/...

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

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, Date of authorisation: 26/08/1997, ...

Aprovel was originally studied in 11 trials for its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use in …

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Published on September 17, 2018 - 12:25 GMT

Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, Date of authorisation: 26/08/1997, ...

Aprovel was originally studied in 11 trials for its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use in …

Distribution channels: Healthcare & Pharmaceuticals Industry