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ec europa eu health documents community-register 2014 anx_127659_en pdf--- worldpharmatoday com boehringer-ingelheim-announced-approval-for-twyn --- europeanpharmaceuticalreview com new-data-confirm-superior-blood-pres --- pharmanews eu 652-european-medicines-agency-approves-twynstarThe European Commission granted a marketing authorisation valid throughout the EU for Twynsta on 7 October 2010 For more information about treatment with Twynsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist --- ema europa eu en medicines human EPAR twynstatheodora com drugs eu twynsta htmlTwynsta contains two active substances, telmisartan and amlodipine Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s They work in similar ways to reduce blood pressure by allowing the blood vessels to relax TWYNSTA® reduced systolic blood pressure by a mean of nearly 50 mmHg This powerful reduction, observed in nearly half of patients, is among the highest blood pressure reduction achieved in antihypertensive trials 1 Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, commented: “We are delighted to receive European approval of TWYNSTA® TWYNSTA® is a combination of the longest acting agents in each class and the study results highlight that more than 71% of diabetes patients with hypertension (baseline BP 161 91mmHg) treated with TWYNSTA® achieved the study-defined blood pressure goal (When Twynsta is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended There is no experience regarding the administration of Twynsta in patients with a recent kidney transplant Telmisartan and amlodipine are not dialysable 14 October 2010 Boehringer Ingelheim Boehringer Ingelheim announced that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA® TWYNSTA® is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy
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