EC approves drug to treat uterine fibroids

Pharma

The European Commission (EC) has granted marketing authorization for 5 mg tablets of Esmya, a drug developed by Preglem, a 100%-owned unit of Hungarian pharmaceutical company Gedeon Richter, for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids, Richter announced on Monday.

This decision follows positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 16, 2011 and is applicable for all European Union member states.

The approval is based on the assessment of extensive pre-clinical data, quality data, and clinical data, which include data from the two-phase III pivotal clinical studies, PEARL I and PEARL II.

Richter acquired PregLem, the Swiss pharmaceutical company that makes Esmya, in October 2010. As a result of the acquisition Richter procured the distribution and marketing rights for the drug in the European Union and in North America.

ADVERTISEMENT

European e-commerce soars during pandemic - study Analysis

European e-commerce soars during pandemic - study

Lawmakers approve 2022 budget Parliament

Lawmakers approve 2022 budget

Duncan Graham reelected as BCCH president Appointments

Duncan Graham reelected as BCCH president

Budapest launches revamped coupon card for visitors City

Budapest launches revamped coupon card for visitors

SUPPORT THE BUDAPEST BUSINESS JOURNAL

Producing journalism that is worthy of the name is a costly business. For 27 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.
Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.