Bayer Welcomes The Proposed EMEA Labeling Changes For Moxifloxacin
July 28th, 2008 | by admin |Bayer is pleased to announce that today theEuropean Medicines Agency’s (EMEA) Committee for Medicinal Products forHuman Use (CHMP) proposed a labeling change for oral moxifloxacin for thetreatment of Acute Exacerbations of Chronic Bronchitis (AECB), AcuteBacterial Sinusitis (ABS) and Community Acquired Pneumonia (CAP) in linewith official European clinical guidelines.
“We welcome the CHMP review which confirms the positive benefit-riskprofile of moxifloxacin as we believe this is an important treatment optionfor patients,” saidDr. Kemal Malik, member of the Bayer HealthCare Executive Committee andChief Medical Officer. “We would also welcome an EMEA assessment of otherantibiotics used for treatment of these infections in a similar fashion inthe interest of patient care.”
“Due to increasing resistance of Streptococcus pneumoniae in Europe,commonly used first line agents may not be appropriate in these countries.Oral moxifloxacin remains an important treatment option in theserespiratory tract infections”, said Prof. Hartmut Lode, Research Center forMedical Studies, Berlin.
On July 14, 2008, the European Commission granted a further indication formoxifloxacin tablets for the treatment of mild to moderate PelvicInflammatory Disease (PID) in all European countries.
About Moxifloxacin
Moxifloxacin is an antimicrobial in the fluoroquinolone class. It ismarketed under the brand names Avelox®, Avalox®, Izilox®, Actira®,Octegra®, Proflox®, Actimax®, Lapinix®, Havelox®, Avelon®, Megaxin® andPromira®. Moxifloxacin has been used in more than 98 million patientsworldwide.
About Bayer
The Bayer Group is a global enterprise with core competencies in the fieldsof health care, nutrition and high-tech materials. Bayer HealthCare, asubsidiary of Bayer AG,is one of the world’s leading, innovative companies in the healthcare andmedical products industry and is based in Leverkusen, Germany. The companycombines the global activities of the Animal Health, Consumer Care,Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals businessoperates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim isto discover and manufacture products that will improve human and animalhealth worldwide. Find more information at http://www.bayerhealthcare.com.
About Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceuticalcompany. Its research and business activities are focused on the followingareas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’sHealthcare. With innovative products, Bayer Schering Pharma aims forleading positions in specialized markets worldwide. Using new ideas, BayerSchering Pharma aims to make a contribution to medical progress and strivesto improve the quality of life. Find more information athttp://www.bayerscheringpharma.de.
Forward-Looking Statements
This release may contain forward-looking statements based on currentassumptions and forecasts made by Bayer Group or subgroup management.Various known and unknown risks, uncertainties and other factors could leadto material differences between the actual future results, financialsituation, development or performance of the company and the estimatesgiven here. These factors include those discussed in Bayer’s public reportswhich are available on the Bayer website at www.bayer.com. The companyassumes no liability whatsoever to update these forward-looking statementsor to conform them to future events or developments.
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