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

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Alofisel, darvadstrocel, Rectal Fistula, Date of authorisation: 23/03/...

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

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

Sitagliptin on its own as Januvia / Xelevia / Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type-2-diabetes patients. The company presented the results of three studies of Januvia / Xelevia to support the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

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

Sitagliptin on its own as Januvia / Xelevia / Tesavel can be used with metformin, and with both metformin and a sulphonylurea, in type-2-diabetes patients. The company presented the results of three studies of Januvia / Xelevia to support the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, ...

The most common side effects with Vyxeos liposomal (which may affect more than 1 in 5 people) are hypersensitivity (allergic reactions, especially rash), febrile neutropenia (low white cell counts with fever), oedema (swelling), diarrhoea, colitis ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, ...

The most common side effects with Vyxeos liposomal (which may affect more than 1 in 5 people) are hypersensitivity (allergic reactions, especially rash), febrile neutropenia (low white cell counts with fever), oedema (swelling), diarrhoea, colitis ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): ellaOne, ulipristal acetate, Contraception, Postcoital, Date of ...

EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies. Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant. This is less than the 5.5% of women who would have been expected to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): ellaOne, ulipristal acetate, Contraception, Postcoital, Date of ...

EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies. Of the women who completed the main study, 2.1% (26 out of 1,241) became pregnant. This is less than the 5.5% of women who would have been expected to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome;Angina, Unstable;Myocardial ...

Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST- …

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Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome;Angina, Unstable;Myocardial ...

Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST- …

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Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome;Prader-Willi Syndrome;Dwarfism, ...

In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:14 GMT

Human medicines European public assessment report (EPAR): Omnitrope, somatropin, Turner Syndrome;Prader-Willi Syndrome;Dwarfism, ...

In adults, side effects related to fluid retention, such as peripheral oedema (swelling, especially of the ankles and feet), paraesthesia (numbness or tingling), joint and muscle pain, and stiffness of the limbs are common (may affect between 1 and 10 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Cablivi, caplacizumab, Purpura, Thrombotic Thrombocytopenic, Date of ...

Two main studies have investigated the effectiveness of Cablivi in patients with aTTP who required plasma exchange to treat their condition. All patients were receiving standard treatment. In the first study, involving 75 patients, platelet counts returned …

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Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Cablivi, caplacizumab, Purpura, Thrombotic Thrombocytopenic, Date of ...

Two main studies have investigated the effectiveness of Cablivi in patients with aTTP who required plasma exchange to treat their condition. All patients were receiving standard treatment. In the first study, involving 75 patients, platelet counts returned …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), mercaptopurine, ...

Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell). Because the number of patients with ALL is low, the disease is considered ‘rare’, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), mercaptopurine, ...

Xaluprine is used to treat children, adolescents and adults who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell). Because the number of patients with ALL is low, the disease is considered ‘rare’, and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:13 GMT

Orphan designation: 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (voxelotor), Treatment of ...

On 18 November 2016, orphan designation (EU/3/16/1769) was granted by the European Commission to SynteractHCR Deutschland GmbH, Germany, for 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde (also known as GBT440) for the …

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Published on September 17, 2018 - 12:13 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Omecamtiv mecarbil, 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 - 12:13 GMT

Opinion/decision on a Paediatric investigation plan (PIP): 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine ...

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 - 12:13 GMT

Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, Date of authorisation: ...

Constella was shown to be more effective than placebo at improving the symptoms of IBS. In the first study, 55% of patients who received Constella experienced a 30% or higher improvement in their pain and discomfort for at least six out of the 12 weeks of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:13 GMT

Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, Date of authorisation: ...

Constella was shown to be more effective than placebo at improving the symptoms of IBS. In the first study, 55% of patients who received Constella experienced a 30% or higher improvement in their pain and discomfort for at least six out of the 12 weeks of …

Distribution channels: Healthcare & Pharmaceuticals Industry