ข่าวประชาสัมพันธ์ Press Releases ข่าวย้อนหลัง หัวข้อข่าว บลอก

Merck Receives Recommendation for Approval in 21 EU Countries for the New Formulation of Euthyrox(R)

Food and Healthcare Press Releases วันพฤหัสบดีที่ ๒๖ กรกฎาคม พ.ศ. ๒๕๖๑ ๑๔:๐๐ น.
ขนาดตัวอักษร: ใหญ่ กลาง เล็ก
DARMSTADT, Germany--26 Jul--PRNewswire/InfoQuest
Not intended for UK- or US-based media
  • German Federal Institute for Drugs and Medical Devices (BfArM) recommends new formulation of Euthyrox(R) for approval in 21 EU countries
  • BfArM is acting as a representative of all 21 EU countries involved in the EU worksharing procedure

Merck, a leading science and technology company, today announced that the German Federal Institute for Drugs and Medical Devices has recommended to approve Merck's new formulation of Euthyrox(R) (levothyroxine) in 21 EU countries. National approvals will be issued following this recommendation.

"The tighter specification of the active ingredient in the new formulation of Euthyrox(R) aims to help patients have better control over their individual levothyroxine dosage," said Steven Hildemann, Global Chief Medical Officer at the Biopharma business of Merck. "Following the positive recommendation from BfArM, Merck will continue to collaborate closely with local Health Authorities, healthcare professionals and patient groups in preparation for the roll out of the new formulation in the 21 countries. Together with the respective stakeholders, and in full compliance with the local regulations, we aim to ensure that patients are appropriately informed. Therefore it is our first priority to support physicians and help them provide their patients with the best possible transition to the new formulation of Euthyrox(R) ."

The German BfArM decision to recommend the approval of the new formulation of Euthyrox(R) across 21 EU states was based on a study demonstrating bioequivalence between the old and new formulations.

Levothyroxine is a synthetically produced hormone that corresponds to the natural thyroid hormone Thyroxin (T4). It is used to treat hypothyroidism, goiter and to suppress TSH in the post-treatment of differentiated thyroid cancer.

The new formulation came at the request of several health authorities worldwide. It was introduced in France in March 2017 and Switzerland in April 2018. Turkish authorities have approved the new formulation and Merck expects to launch the medicine there in the course of 2018.

For thyroid drugs a small dosage variation might impact the patient's thyroid balance. Prescribing doctors are therefore encouraged to monitor patients closely when prescribing the new formulation and to adjust the individual dosage if medically required. Along with Health Authorities, Merck recommends that all patients do not switch or stop their treatment without medical advice and refer to their prescribing physician to potentially adjust the medication dose to their individual need during the transition phase.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Almost 53,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2017, Merck generated sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Sara Yussefi
+49-151-14546690
Sara.yussefi@merckgroup.com
(Logo: https://mma.prnewswire.com/media/554117/Merck_Logo.jpg )
Source: Merck

ขนาดตัวอักษร: ใหญ่ กลาง เล็ก

ข่าวประชาสัมพันธ์ที่เกี่ยวข้อง

Vendor News from the Asian Banker E-Newsletter (January 20, 2003)

A US council composed of the Office of the Comptroller of the Currency, the Federal Reserve, the Federal Deposit Insurance Corp, and the Office of Thrift Supervision has released new rules focused on subprime lenders catering to credit card clients with p...

ADHD Cure?

Can't study? Can t Focus? Mind wandering? Do you have ADHD? Biotrex Vitamins has a new vitamin formula that improves your attention span naturally. Can t Focus? Mind wandering? Biotrex Vitamins has a new formula that improves attention span naturally. Can...

US: AIMR recommends 10 'New Year's resolutions for investment community

If there ever was a time for the entire investment community - including investors and corporate issuers - to reassess their actions and attitudes, it is now. The Association for Investment Management and Research? (AIMR?) suggests 10 New Year's resolutio...

หัวข้อข่าวที่เกี่ยวข้อง

หัวข้อข่าวยอดนิยม

กรมสรรพากร ธนาคารกรุงเทพ ธนาคารกรุงไทย ธนาคารออมสิน ไปรษณีย์ไทย การบินไทย ธนาคารกสิกรไทย hotmai เพียวริคุ jobbkk ธนาคารไทยพาณิชย์ คาราบาว ดีแทค ไทยพาณิชย์ แจ่มใส เมเจอร์ ธนาคารอาคารสงเคราะห์ 12car กรุงไทย ธนาคารกรุงศรีอยุธยา กระทรวงสาธารณสุข การรถไฟแห่งประเทศไทย มิตซูบิชิ เมืองทอง ธนาคารทหารไทย ตลาดหลักทรัพย์แห่งประเทศไทย ซัมซุง มาม่า วันทูคอล ธนาคารแห่งประเทศไทย กระทรวงพาณิชย์ เวลาประเทศไทย ปตท ธอส บิ๊กซี กรมอุตุ กรมศุลกากร แม็คโคร ธนาคารกรุงศรี กระทรวงการคลัง