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Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): STELARA, USTEKINUMAB, PSORIASIS,ARTHRITIS, PSORIATIC,CROHN DISEASE, DATE OF AUTHORISATION: , REVISION: 28, STATUS: AUTHORISED

Redazione
by Redazione05
(AGENPARL) – London (United Kingdom), gio 12 settembre 2019 Plaque psoriasis In the treatment of moderate to severe plaque psoriasis, Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with the condition. In over half of these patients other treatments......
Agenparl English Arte, cultura, intrattenimento Educazione Salute Scienza e Tecnologia

FENOFIBRIC ACID TABLET [SARRAS HEALTH, LLC]

Redazione
by Redazione010
(AGENPARL) – Bethesda (Maryland), dom 08 settembre 2019 5.1 Mortality and Coronary Heart Disease Morbidity The effect of fenofibric acid tablets on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been established. The Action to Control Cardiovascular Risk in Diabetes Lipid (ACCORD Lipid) trial was a randomized......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): VIMPAT, LACOSAMIDE, EPILEPSY, DATE OF AUTHORISATION: , REVISION: 30, STATUS: AUTHORISED

Redazione
by Redazione010
(AGENPARL) – London (United Kingdom), gio 05 settembre 2019 Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines. Patients were given Vimpat by mouth at a dose......
Agenparl English Educazione Scienza e Tecnologia Social Network

THE EFFECTS OF RESVERATROL ON METABOLIC STATUS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CORONARY HEART DISEASE

Redazione
by Redazione08
(AGENPARL) – London (United Kingdom), gio 05 settembre 2019 This study was performed to investigate the effects of resveratrol on metabolic status in patients with type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD). This randomized, double-blind, placebo-controlled trial was performed with 56 patients having T2DM and CHD. The......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): XIGDUO, DAPAGLIFLOZIN / METFORMIN, DIABETES MELLITUS, TYPE 2, DATE OF AUTHORISATION: , REVISION: 14, STATUS: AUTHORISED

Redazione
by Redazione013
(AGENPARL) – London (United Kingdom), gio 29 agosto 2019 Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes. The majority of these data had already been used in the authorisation of Forxiga. In one main study, when dapagliflozin was used at......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): EBYMECT, DAPAGLIFLOZIN / METFORMIN, DIABETES MELLITUS, TYPE 2, DATE OF AUTHORISATION: , REVISION: 11, STATUS: AUTHORISED

Redazione
by Redazione013
(AGENPARL) – London (United Kingdom), mer 28 agosto 2019 Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes. The majority of these data had already been used in the authorisation of Forxiga. In one main study, when dapagliflozin was used at......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): STAYVEER, BOSENTAN MONOHYDRATE, HYPERTENSION, PULMONARY,SCLERODERMA, SYSTEMIC, DATE OF AUTHORISATION: , REVISION: 9, STATUS: AUTHORISED

Redazione
by Redazione012
(AGENPARL) – London (United Kingdom), mar 27 agosto 2019 In PAH, Stayveer has been studied in four main studies: two in a total of 245 adults with class-III or -IV disease that was either primary or caused by scleroderma, one in 54 adults with class-III PAH that was associated with......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): TRACLEER, BOSENTAN, SCLERODERMA, SYSTEMIC,HYPERTENSION, PULMONARY, DATE OF AUTHORISATION: , REVISION: 35, STATUS: AUTHORISED

Redazione
by Redazione014
(AGENPARL) – London (United Kingdom), lun 26 agosto 2019 In class III or IV PAH that was either primary or caused by scleroderma, the two studies showed that patients treated with Tracleer were able to walk further than patients treated with placebo after 16 weeks (44 metres further in the......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): MIMPARA, CINACALCET, HYPERCALCEMIA,PARATHYROID NEOPLASMS,HYPERPARATHYROIDISM, DATE OF AUTHORISATION: , REVISION: 21, STATUS: AUTHORISED

Redazione
by Redazione019
(AGENPARL) – London (United Kingdom), gio 22 agosto 2019 Secondary hyperparathyroidism Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 adults with secondary hyperparathyroidism who were on dialysis because they had a serious kidney disease. The main measure of effectiveness was the number of......
Agenparl English Diritto & Giustizia Salute Social Network

HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): KALYDECO, IVACAFTOR, CYSTIC FIBROSIS, DATE OF AUTHORISATION: , REVISION: 18, STATUS: AUTHORISED

Redazione
by Redazione017
(AGENPARL) – London (United Kingdom), mar 20 agosto 2019 G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations. The main measure of effectiveness in these......

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