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

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Hycamtin, topotecan, Ovarian Neoplasms;Uterine Cervical Neoplasms;Small ...

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan is indicated for the treatment of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Thalidomide BMS (previously Thalidomide Celgene), thalidomide, Multiple ...

Most patients taking thalidomide get side effects. The most common side effects with Thalidomide BMS used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Thalidomide BMS (previously Thalidomide Celgene), thalidomide, Multiple ...

Most patients taking thalidomide get side effects. The most common side effects with Thalidomide BMS used together with melphalan and prednisone (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Tandemact, pioglitazone,glimepiride, Diabetes Mellitus, Type 2, Date of ...

The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Tandemact, pioglitazone,glimepiride, Diabetes Mellitus, Type 2, Date of ...

The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 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.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

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

Bydureon was effective at controlling blood glucose in six main studies involving nearly 2700 patients with type 2 diabetes. In all of the studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

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

Bydureon was effective at controlling blood glucose in six main studies involving nearly 2700 patients with type 2 diabetes. In all of the studies, the main measure of effectiveness was the reduction in the amount of a substance in the blood called …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), ...

Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), ...

Hexacima has been studied in several countries worldwide in 12 main studies involving over 3,400 children between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Foclivia, pandemic influenza vaccine (H5N1) (surface antigen, ...

Foclivia is a ‘pandemic preparedness’ vaccine. This is a special type of vaccine that can be developed to help with the management of a future pandemic. Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

Human medicines European public assessment report (EPAR): Foclivia, pandemic influenza vaccine (H5N1) (surface antigen, ...

Foclivia is a ‘pandemic preparedness’ vaccine. This is a special type of vaccine that can be developed to help with the management of a future pandemic. Before a pandemic starts, nobody knows which strain of flu virus will be involved, so companies cannot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:11 GMT

CHMP opinions on consultation procedures

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 - 12:10 GMT

Orphan designation: Nimorazole, Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy, 23/...

At the time of designation, squamous cell carcinoma of the head and neck in patients undergoing radiotherapy affected less than 4 in 10,000 people in the European Union (EU)*. This is equivalent to a total of fewer than 202,000 people, and is below the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Paracetamol product-specific bioequivalence guidance

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 - 12:10 GMT

Guidance on good manufacturing practice and good distribution practice: Questions and answers

Suspected product quality defects (e.g. product deterioration, packaging mix-up, among others) should be reported to the competent authority with responsibility for the manufacturing site (or importer where the manufacturer is located outside the EEA), and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Harvoni, ledispavir,sofosbuvir, Hepatitis C, Chronic, Date of ...

Harvoni has been investigated in three main studies involving a total of around 2,000 adults infected with hepatitis C virus of genotype 1 whose liver function was normal. In all three studies, the main measure of effectiveness was the number of patients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Harvoni, ledispavir,sofosbuvir, Hepatitis C, Chronic, Date of ...

Harvoni has been investigated in three main studies involving a total of around 2,000 adults infected with hepatitis C virus of genotype 1 whose liver function was normal. In all three studies, the main measure of effectiveness was the number of patients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:10 GMT

Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline

This guideline applies to human and veterinary medicines. This document describes the process for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches for use in the development and quality control during production of …

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Published on September 17, 2018 - 12:10 GMT

Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus vaccine [types 16, 18] (recombinant, ...

Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix. In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV …

Distribution channels: Healthcare & Pharmaceuticals Industry