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

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia;Diabetic Neuropathies;Depressive ...

Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia;Diabetic Neuropathies;Depressive ...

Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg). ‘Gastroresistant’ means that the capsules’ contents pass through the stomach without being broken down until they reach the intestine. This prevents the active substance being …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ninlaro, ixazomib, Multiple Myeloma, Date of authorisation: 21/11/2016, ...

Data from the main study indicate that Ninlaro improves patients’ progression-free survival. However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Ninlaro, ixazomib, Multiple Myeloma, Date of authorisation: 21/11/2016, ...

Data from the main study indicate that Ninlaro improves patients’ progression-free survival. However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Orphan designation: Lentiviral vector carrying the Fanconi anaemia-A (FANCA) gene, Treatment of Fanconi anaemia type A, 17/12/2010,...

At the time of designation, Fanconi anaemia type A affected between 0.01 and 0.05 in 10,000 people in the European Union (EU). This was equivalent to a total of between 500 and 2,500 people*, and is below the ceiling for orphan designation, which is 5 …

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Published on September 17, 2018 - 12:28 GMT

Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human ...

On 28 January 2010, orphan designation (EU/3/09/709) was granted by the European Commission to Apogenix GmbH, Germany, for recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for the …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic ...

Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic ...

Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Immunization, Passive;...

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior …

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Published on September 17, 2018 - 12:28 GMT

Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Immunization, Passive;...

Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior …

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Published on September 17, 2018 - 12:28 GMT

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

Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Januvia 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% …

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Published on September 17, 2018 - 12:28 GMT

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

Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines. In patients taking Januvia 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% …

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Published on September 17, 2018 - 12:28 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Adasuve,loxapine, 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): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge;Urinary ...

The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation. For the full list of all side effects reported with Emselex, see the package leaflet. Emselex must not be used in people who are hypersensitive ( …

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Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Emselex, darifenacin hydrobromide, Urinary Incontinence, Urge;Urinary ...

The most common side effects with Emselex (seen in more than 1 patient in 10) are dry mouth and constipation. For the full list of all side effects reported with Emselex, see the package leaflet. Emselex must not be used in people who are hypersensitive ( …

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 …

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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 …

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Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms;Breast Neoplasms, Date of ...

Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for …

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Published on September 17, 2018 - 12:27 GMT

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms;Breast Neoplasms, Date of ...

Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for …

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