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

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide,formoterol, Pulmonary Disease, Chronic ...

BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide,formoterol, Pulmonary Disease, Chronic ...

BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Orphan designation: Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-...

This medicine is now known as lutetium (177Lu) oxodotreotide. On 31 January 2008, orphan designation (EU/3/07/523) was granted by the European Commission to BioSynthema Global Operations B.V, the Netherlands, for lutetium (177Lu)-N-[(4,7,10- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Soft Tissue Infections;Skin ...

Tenkasi, given as a single infusion, was compared with a 7- to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Tenkasi (previously Orbactiv), oritavancin, Soft Tissue Infections;Skin ...

Tenkasi, given as a single infusion, was compared with a 7- to 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1,959 patients with acute bacterial infections of the skin and of skin structures, such …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Cinqaero, reslizumab, Asthma, Date of authorisation: 15/08/2016, ...

In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs. The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Cinqaero, reslizumab, Asthma, Date of authorisation: 15/08/2016, ...

In eosinophilic asthma, symptoms are associated with having too many of a type of white blood cell called eosinophils in the blood and in phlegm in the lungs. The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to attach to a …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,edoxaban tosilate, decision type: , therapeutic area: , PIP ...

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 - 12:19 GMT

Human medicines European public assessment report (EPAR): Aldara, imiquimod, Condylomata Acuminata;Keratosis;Keratosis, Actinic;...

The active substance in Aldara cream, imiquimod, is an immune-response modifier. This means that it uses the immune system, the body’s natural defences, to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Aldara, imiquimod, Condylomata Acuminata;Keratosis;Keratosis, Actinic;...

The active substance in Aldara cream, imiquimod, is an immune-response modifier. This means that it uses the immune system, the body’s natural defences, to bring about its effect. When imiquimod is applied to the skin, it acts locally on the immune system …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol,delta-9-tetrahydrocannabinol, decision type: , therapeutic ...

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 - 12:19 GMT

Demonstration of efficacy of ectoparasiticides - Scientific guideline

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 - 12:19 GMT

Human medicines European public assessment report (EPAR): Caelyx pegylated liposomal, doxorubicin, Sarcoma, Kaposi;Multiple ...

Caelyx pegylated liposomal has been studied in a total of 2,512 patients in seven main studies. For metastatic breast cancer, in a study involving 509 women, Caelyx pegylated liposomal was as effective as standard doxorubicin: the time until the disease …

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Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Caelyx pegylated liposomal, doxorubicin, Sarcoma, Kaposi;Multiple ...

Caelyx pegylated liposomal has been studied in a total of 2,512 patients in seven main studies. For metastatic breast cancer, in a study involving 509 women, Caelyx pegylated liposomal was as effective as standard doxorubicin: the time until the disease …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Kivexa, abacavir,lamivudine, HIV Infections, Date of authorisation: 16/...

The most common side effects with Kivexa (which may affect up to 1 in 10 people) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal (belly) pain, headache, joint pain, muscle disorders, cough, nasal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Kivexa, abacavir,lamivudine, HIV Infections, Date of authorisation: 16/...

The most common side effects with Kivexa (which may affect up to 1 in 10 people) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal (belly) pain, headache, joint pain, muscle disorders, cough, nasal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Cosentyx, secukinumab, Arthritis, Psoriatic;Psoriasis;Spondylitis, ...

Plaque psoriasis Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and axial spondyloarthritis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Cosentyx, secukinumab, Arthritis, Psoriatic;Psoriasis;Spondylitis, ...

Plaque psoriasis Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and axial spondyloarthritis, with patients showing greater improvements with Cosentyx than with placebo (a dummy treatment) or with a comparator medicine, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Galafold, migalastat, Fabry Disease, Date of authorisation: 25/05/2016, ...

Galafold has been investigated in two main studies involving a total of 127 patients aged over 16 years with Fabry disease. The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:19 GMT

Human medicines European public assessment report (EPAR): Galafold, migalastat, Fabry Disease, Date of authorisation: 25/05/2016, ...

Galafold has been investigated in two main studies involving a total of 127 patients aged over 16 years with Fabry disease. The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who …

Distribution channels: Healthcare & Pharmaceuticals Industry