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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): DUPIXENT, DUPILUMAB, DERMATITIS, ATOPIC, DATE OF AUTHORISATION: 27/09/2017, REVISION: 9, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), sab 23 gennaio 2021 Atopic dermatitis Dupixent was more effective than placebo (a dummy treatment) at reducing the extent and severity of atopic dermatitis in 3 main studies in patients with moderate to severe disease. In the first study, which involved 740 patients, participants were......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): OSLIF BREEZHALER, INDACATEROL, PULMONARY DISEASE, CHRONIC OBSTRUCTIVE, DATE OF AUTHORISATION: 29/11/2009, REVISION: 16, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), gio 21 gennaio 2021 In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). The main measure of effectiveness was based on changes in the patients’......
Agenparl English Educazione Scienza e Tecnologia Social Network

POLYMETHOXYFLAVONE PURIFIED FROM KAEMPFERIA PARVIFLORA REDUCES VISCERAL FAT IN JAPANESE OVERWEIGHT INDIVIDUALS: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), gio 14 gennaio 2021 Visceral fat is a more important factor in obesity-associated disorders in Japanese individuals than in Caucasian individuals. The objective of this randomised, double-blind, placebo-controlled parallel group study, conducted in Japanese overweight adults, was to investigate the effects of polymethoxyflavone purified from......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): OFEV, NINTEDANIB, IDIOPATHIC PULMONARY FIBROSIS, DATE OF AUTHORISATION: 14/01/2015, REVISION: 16, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), lun 04 gennaio 2021 Ofev has been compared with placebo (a dummy treatment) in four main studies involving a total of 1,066 patients with IPF, 580 patients with systemic sclerosis associated interstitial lung disease and 663 patients with progressive fibrosing interstitial lung disease. In all......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): QUINSAIR, LEVOFLOXACIN, CYSTIC FIBROSIS,RESPIRATORY TRACT INFECTIONS, DATE OF AUTHORISATION: 25/03/2015, REVISION: 12, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), mar 15 dicembre 2020 Quinsair has been investigated in two main studies in patients who had cystic fibrosis with P. aeruginosa lung infection. The first study, which involved 330 patients, compared Quinsair with placebo (a dummy treatment), while the second, involving 282 patients, compared it......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): MYSIMBA, NALTREXONE,BUPROPION, OBESITY,OVERWEIGHT, DATE OF AUTHORISATION: 26/03/2015, REVISION: 18, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), lun 14 dicembre 2020 The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment). Patients in the studies were given the medicine as......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): REPATHA, EVOLOCUMAB, DYSLIPIDEMIAS,HYPERCHOLESTEROLEMIA, DATE OF AUTHORISATION: 17/07/2015, REVISION: 15, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), ven 11 dicembre 2020 Hypercholesterolaemia and mixed dyslipidaemia In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in 9 main studies involving around 7,400 adult patients, including patients with heterozygous familial disease. Some of the studies looked at Repatha taken on its own, while others......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): XELJANZ, TOFACITINIB, ARTHRITIS, RHEUMATOID, DATE OF AUTHORISATION: 21/03/2017, DATE OF REFUSAL: 25/04/2013, REVISION: 14, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), gio 10 dicembre 2020 Rheumatoid arthritis Six studies in over 4,200 patients with rheumatoid arthritis have shown that Xeljanz is effective at reducing joint pain and swelling, improving joint movement and slowing down joint damage. Most patients in these studies had tried other treatments before......
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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): KALYDECO, IVACAFTOR, CYSTIC FIBROSIS, DATE OF AUTHORISATION: 23/07/2012, REVISION: 26, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), mer 09 dicembre 2020 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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HUMAN MEDICINES EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR): SPEDRA, AVANAFIL, ERECTILE DYSFUNCTION, DATE OF AUTHORISATION: 21/06/2013, DATE OF REFUSAL: 26/04/2013, REVISION: 12, STATUS: AUTHORISED

Redazione
(AGENPARL) – LONDON (UNITED KINGDOM), ven 20 novembre 2020 Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction. The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked......

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