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There were 1,919 press releases posted in the last 24 hours and 431,418 in the last 365 days.

Press Releases on September 17, 2018

1,839 Press Releases

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Deltyba, delamanid, Tuberculosis, Multidrug-Resistant, Date of ...

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Deltyba, delamanid, Tuberculosis, Multidrug-Resistant, Date of ...

Deltyba is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, Date of authorisation: 25/...

Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants. Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Bridion, sugammadex, Neuromuscular Blockade, Date of authorisation: 25/...

Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants. Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, Date of authorisation: 25/...

People who smoke become addicted to nicotine, a chemical in tobacco. Nicotine acts in the nervous system, where it binds to receptors and triggers the release of a chemical messenger, dopamine, which plays a part in the pleasure derived from smoking. The …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, Date of authorisation: 25/...

People who smoke become addicted to nicotine, a chemical in tobacco. Nicotine acts in the nervous system, where it binds to receptors and triggers the release of a chemical messenger, dopamine, which plays a part in the pleasure derived from smoking. The …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, Date of authorisation: 17/03/...

The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo,betibeglogene autotemcel, decision type: , therapeutic area: , ...

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 - 12:02 GMT

Human medicines European public assessment report (EPAR): Jevtana, cabazitaxel, Prostatic Neoplasms, Date of authorisation: 17/03/...

The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Risk management plans

Companies are required submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation. To help applicants, guidance is available on how to submit RMPs. RMPs include information on: a medicine's …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Orphan designation: Enzastaurin hydrochloride, Treatment of diffuse large B-cell lymphoma, 20/03/2007, Withdrawn

Based on the information provided by the sponsor and previous knowledge of the Committee, DLBCL was considered to affect less than 2 in 10,000 persons in the European Union, which, at the time of designation, corresponded to about 100,000 persons. * …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Scientific ...

VICH GL18(R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients - Revision 1 (PDF/182.71 KB) Adopted First published: 26/09/2011 Last updated: 26/09/2011 Legal effective date: 01/07/2012 EMA/CVMP/VICH/502/ …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Gazyvaro, obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, Date of ...

Chronic Lymphocytic Leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Human medicines European public assessment report (EPAR): Gazyvaro, obinutuzumab, Leukemia, Lymphocytic, Chronic, B-Cell, Date of ...

Chronic Lymphocytic Leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:02 GMT

Nutritional High Receives Oregon Marijuana Processor License

TORONTO, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Nutritional High International Inc. (the "Company" or "Nutritional High") (CSE: EAT, OTCQB: SPLIF, FRANKFURT:2NU) is pleased to announce that the Oregon Liquor Control Commission has granted a …

Distribution channels: Food & Beverage Industry, Law ...
Published on September 17, 2018 - 12:01 GMT

Human medicines European public assessment report (EPAR): Nordimet, methotrexate, Arthritis, Psoriatic;Psoriasis;Arthritis, ...

The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:01 GMT

Human medicines European public assessment report (EPAR): Nordimet, methotrexate, Arthritis, Psoriatic;Psoriasis;Arthritis, ...

The most common side effects with Nordimet (which may affect more than 1 in 10 people) are effects in the digestive system (such as inflammation of the lining of the mouth, indigestion, belly pain, feeling sick and loss of appetite) and blood tests showing …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:01 GMT

Human medicines European public assessment report (EPAR): Refixia, nonacog beta pegol, Hemophilia B, Date of authorisation: 02/06/...

Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:01 GMT

Human medicines European public assessment report (EPAR): Refixia, nonacog beta pegol, Hemophilia B, Date of authorisation: 02/06/...

Hypersensitivity (allergic) reactions are uncommon with Refixia (may affect up to 1 in 100 patients) and may include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 17, 2018 - 12:01 GMT

Human medicines European public assessment report (EPAR): Pravafenix, fenofibrate,pravastatin, Dyslipidemias, Date of ...

The most common side effects with Pravafenix (seen in between 1 and 10 patients in 100) are abdominal distension (bloating), abdominal pain (stomach ache), constipation, diarrhoea, dry mouth, dyspepsia (heartburn), eructation (belching), flatulence (gas), …

Distribution channels: Healthcare & Pharmaceuticals Industry

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