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

Published on September 17, 2018 - 12:04 GMT

Orphan designation: Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene, Treatment of ...

At the time of designation, severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency affected approximately 0.02 in 10,000 people in the European Union (EU). This was equivalent to a total of around 900 people*, and is below the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:04 GMT

Human medicines European public assessment report (EPAR): Crysvita, burosumab, Hypophosphatemia, Familial;Hypophosphatemic Rickets,...

X-linked hypophosphataemia Crysvita reduced the severity of rickets (bone deformities) as shown in X-rays in patients with X-linked hypophosphataemia. The medicine was assessed in one main study in 52 children aged between 5 and 12 years. All the children …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:04 GMT

Human medicines European public assessment report (EPAR): Crysvita, burosumab, Hypophosphatemia, Familial;Hypophosphatemic Rickets,...

X-linked hypophosphataemia Crysvita reduced the severity of rickets (bone deformities) as shown in X-rays in patients with X-linked hypophosphataemia. The medicine was assessed in one main study in 52 children aged between 5 and 12 years. All the children …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:04 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Bylvay,Odevixibat, 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.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Synflorix, pneumococcal polysaccharide conjugate vaccine (adsorbed), ...

Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae. The children were followed up for an average of around 2 years. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Synflorix, pneumococcal polysaccharide conjugate vaccine (adsorbed), ...

Synflorix was evaluated in a large study involving over 30,000 infants below 7 months of age who were given either Synflorix or a comparator vaccine which was not active against S. pneumoniae. The children were followed up for an average of around 2 years. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:04 GMT

Human medicines European public assessment report (EPAR): Pegasys, peginterferon alfa-2a, Hepatitis C, Chronic;Hepatitis B, ...

Chronic hepatitis B Adult patients Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:04 GMT

Human medicines European public assessment report (EPAR): Pegasys, peginterferon alfa-2a, Hepatitis C, Chronic;Hepatitis B, ...

Chronic hepatitis B Adult patients Pegasys is indicated for the treatment of hepatitis B envelope antigen (HBeAg)-positive or HBeAg-negative chronic hepatitis B (CHB) in adult patients with compensated liver disease and evidence of viral replication, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Peripheral Vascular Diseases;Stroke;...

Clopidogrel Krka is available as tablets containing 75 mg clopidogrel. The standard dose is one 75-mg tablet once a day. In acute coronary syndrome, treatment generally starts with a loading dose of four tablets. This is then followed by the standard 75-mg …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Clopidogrel Krka, clopidogrel, Peripheral Vascular Diseases;Stroke;...

Clopidogrel Krka is available as tablets containing 75 mg clopidogrel. The standard dose is one 75-mg tablet once a day. In acute coronary syndrome, treatment generally starts with a loading dose of four tablets. This is then followed by the standard 75-mg …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Beyfortus,Nirsevimab, decision type: , therapeutic area: , PIP number: ...

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 - 12:03 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,Ceftazidime,Avibactam, 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 - 12:03 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Avacopan, decision type: , therapeutic area: , PIP number: P/0266/2022

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 - 12:03 GMT

Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab, decision type: , therapeutic area: , PIP number: P/0367/...

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 - 12:03 GMT

Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan,hydrochlorothiazide, Essential Hypertension, ...

Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan,hydrochlorothiazide, Essential Hypertension, ...

Treatment of essential hypertension. Actelsar HCT fixed-dose combination (40 mg telmisartan / 12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone. Actelsar HCT fixed-dose combination ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

EudraVigilance training and support

The online competency assessment process aims to help non-commercial sponsors of clinical trials who intend to submit ICSRs electronically for the first time to register with the EudraVigilance production environment after one user has successfully …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ ...

Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:03 GMT

Human medicines European public assessment report (EPAR): Strimvelis, autologous CD34+ enriched cell fraction that contains CD34+ ...

Strimvelis is a medicine used to treat severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). ADA-SCID is a rare inherited condition in which there is a change (mutation) in the gene needed to make an enzyme called adenosine …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2018 - 12:02 GMT

Apotheca Biosciences (PCFP) Overviews Pain-Patch, an Opioid Substitution

Saint Petersburg, FL, Sept. 17, 2018 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Apotheca Biosciences (OTC PINK: PCFP), a developer of cutting-edge medical products, nutraceuticals, drug formulations and cannabis delivery technologies for the healthcare and …

Distribution channels: Healthcare & Pharmaceuticals Industry