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

Published on September 17, 2018 - 12:06 GMT

Orphan designation: cholic acid, Treatment of inborn errors in primary bile acid synthesis, 18/12/2002, Positive

On 18 December 2002, orphan designation (EU/3/02/127) was granted by the European Commission to Agence Générale des Equipements et Produits de Santé - Etablissement Pharmaceutique des Hôpitaux de Paris (AGEPS - EPHP), France, for cholic acid for the …

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Published on September 17, 2018 - 12:06 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Enasidenib, decision type: , therapeutic area: , PIP number: P/0456/...

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 - 12:06 GMT

Opinion/decision on a Paediatric investigation plan (PIP): outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254,...

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 - 12:05 GMT

Human medicines European public assessment report (EPAR): Xenical, orlistat, Obesity, Date of authorisation: 29/07/1998, Revision: ...

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Xenical, orlistat, Obesity, Date of authorisation: 29/07/1998, Revision: ...

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine. If you need more …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:06 GMT

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

Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes. Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two …

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Published on September 17, 2018 - 12:06 GMT

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

Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes. Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two …

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Published on September 17, 2018 - 12:06 GMT

Orphan designation: , Treatment of Fabry disease, 22/08/2014, Positive

This medicine is now known as venglustat. On 22 August 2014, orphan designation (EU/3/14/1310) was granted by the European Commission to Genzyme Europe BV, the Netherlands, for (3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan- …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Myeloproliferative Disorders;Polycythemia Vera;...

In myelofibrosis, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), bleeding, bruising, …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib, Myeloproliferative Disorders;Polycythemia Vera;...

In myelofibrosis, the most common side effects with Jakavi (which may affect more than 1 in 10 people) include thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), bleeding, bruising, …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Evicel, human fibrinogen,human thrombin, Hemostasis, Surgical, Date of ...

As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly. In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting. …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Evicel, human fibrinogen,human thrombin, Hemostasis, Surgical, Date of ...

As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly. In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting. …

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Published on September 17, 2018 - 12:05 GMT

Orphan designation: N-[(2S)-5-{[(1R, 2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,...

At the time of designation, myelofibrosis affected less than 1 in 10,000 people in the European Union (EU). This was equivalent to a total of fewer than 51,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. This is …

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Published on September 17, 2018 - 12:05 GMT

Product-specific bioequivalence guidance

This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence. Product-specific guidance helps …

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Published on September 17, 2018 - 12:05 GMT

Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene, Treatment of achromatopsia caused ...

At the time of designation, achromatopsia caused by mutations in the CNGA3 gene affected less than 0.3 in 10,000 people in the European Union (EU). This was equivalent to a total of fewer than 15,000 people*, and is below the ceiling for orphan designation …

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Published on September 17, 2018 - 12:05 GMT

Opinion/decision on a Paediatric investigation plan (PIP):…

3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678)

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Published on September 17, 2018 - 12:05 GMT

Orphan designation: Entinostat, Treatment of Hodgkin's lymphoma, 10/06/2010, Positive

At the time of designation, Hodgkin's lymphoma affected between 1 and 4 in 10,000 people in the European Union (EU). This was equivalent to a total of between 51,000 and 203,000 people*, and is below the threshold for orphan designation, which is 5 …

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Published on September 17, 2018 - 12:05 GMT

Opinion/decision on a Paediatric investigation plan (PIP): aluminium hydroxide adsorbed,depigmented glutaraldehyde polymerised,...

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 - 12:05 GMT

Human medicines European public assessment report (EPAR): Mysildecard, sildenafil, Hypertension, Pulmonary, Date of authorisation: ...

Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with …

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Published on September 17, 2018 - 12:05 GMT

Human medicines European public assessment report (EPAR): Mysildecard, sildenafil, Hypertension, Pulmonary, Date of authorisation: ...

Adults Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with …

Distribution channels: Healthcare & Pharmaceuticals Industry