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

Published on September 17, 2018 - 12:06 GMT

Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union

EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO) (PDF/403.68 KB) First published: 01/04/2009 Last updated: 20/05/2021 EMA/534107 …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Hypertension, Pulmonary, Date of authorisation: 20/...

Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH). PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. Opsumit …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Hypertension, Pulmonary, Date of authorisation: 20/...

Opsumit is a medicine used for the long-term treatment of pulmonary arterial hypertension (PAH). PAH is a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. Opsumit …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia;Hematopoietic Stem Cell ...

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Nivestim, filgrastim, Neutropenia;Hematopoietic Stem Cell ...

Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, Date of authorisation: 19/01/2015,...

Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults. Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, Date of authorisation: 19/01/2015,...

Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults. Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone …

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Published on September 17, 2018 - 12:06 GMT

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

Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes. The majority of these data had already been used in the authorisation of Forxiga. In one main study, when dapagliflozin was used at a …

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Published on September 17, 2018 - 12:06 GMT

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

Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes. The majority of these data had already been used in the authorisation of Forxiga. In one main study, when dapagliflozin was used at a …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Yervoy, ipilimumab, Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-...

Advanced melanoma Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma. In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Yervoy, ipilimumab, Melanoma;Carcinoma, Renal Cell;Carcinoma, Non-Small-...

Advanced melanoma Several studies have shown that Yervoy is effective in prolonging the lives of patients with advanced melanoma. In a study involving 676 adults in whom previous treatment for advanced melanoma had not worked or had stopped working, …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, Date of authorisation:...

Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm, levetiracetam, Epilepsy, Date of authorisation:...

Levetiracetam ratiopharm is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam ratiopharm is indicated as adjunctive …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Ivabradine Zentiva, ivabradine, Angina Pectoris;Heart Failure, Date of ...

The symptoms of angina are caused by the heart not receiving enough oxygenated blood. In stable angina, these symptoms occur during physical effort. The active substance in Ivabradine Zentiva, ivabradine, blocks the ‘If current’ in the sinus node, the …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Ivabradine Zentiva, ivabradine, Angina Pectoris;Heart Failure, Date of ...

The symptoms of angina are caused by the heart not receiving enough oxygenated blood. In stable angina, these symptoms occur during physical effort. The active substance in Ivabradine Zentiva, ivabradine, blocks the ‘If current’ in the sinus node, the …

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Published on September 17, 2018 - 12:06 GMT

Orphan designation: 4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin), Treatment of moderate and severe ...

On 28 August 2006, orphan designation (EU/3/06/390) was granted by the European Commission to vasopharm BIOTECH GmbH, Germany, for 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the treatment of moderate and severe traumatic brain injury …

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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

Human medicines European public assessment report (EPAR): Pradaxa, dabigatran etexilate, Arthroplasty, Replacement;Venous ...

Prevention of blood clots after hip or knee replacement Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement …

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Published on September 17, 2018 - 12:06 GMT

Human medicines European public assessment report (EPAR): Pradaxa, dabigatran etexilate, Arthroplasty, Replacement;Venous ...

Prevention of blood clots after hip or knee replacement Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement …

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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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