BAYER AG 
By
Friday - January 27, 2012
Not intended for U.S. and UK media - Indication extension for contrast medium
Bayer receives green light from EU authorities to use Gadovist® 1.0 in children aged two years and older
Berlin, January 27, 2012 - Bayer HealthCare successfully
completed the procedure to get approval for use of the
contrast medium Gadovist® 1.0 in children aged two to six
years in the Europe Union and markets like Germany, France,
Spain, Italy and UK. Use in children aged seven years and
above has already been approved since 2009. Germany will
start to introduce Gadovist® 1.0 for this expanded
indication immediately.
Gadovist is approved for the most frequently conducted contrast enhanced magnetic resonance tomography (MRT) examinations. These include examinations of the central nervous system, blood vessels and imaging of the liver and the kidney. Gadovist has already been approved for this younger patient population in many countries outside the EU incl. the US, Brazil, China, Korea and Canada and was already approved in the EU for kids of seven years and above.
The clinical study, which supports the indication extension for Gadovist, involved 138 children and adolescents who were scheduled for a contrast-enhanced MRT scan. The study investigated the pharmacokinetics (distribution and excretion) as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that Gadovist is well-tolerated in this patient group too. The study also confirmed that the dosage recommendation based on body weight, which is routine in adults, is also appropriate for the use of Gadovist in children.
About Gadovist
Gadovist is a modern macrocyclic, highly efficient MRT contrast agent. It is approved for the contrast-enhanced MRT of various parts of the body, including the brain, the spinal chord, the liver, the kidney and the blood-vessel system. With its 1.0 mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market. Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per mL of all gadolinium based contrast media. This results in excellent image quality and offers practical advantages, like smaller injection volumes. Gadovist was approved for the first time in 1998 and is now approved in over 80 countries.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at .
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Gadovist is approved for the most frequently conducted contrast enhanced magnetic resonance tomography (MRT) examinations. These include examinations of the central nervous system, blood vessels and imaging of the liver and the kidney. Gadovist has already been approved for this younger patient population in many countries outside the EU incl. the US, Brazil, China, Korea and Canada and was already approved in the EU for kids of seven years and above.
The clinical study, which supports the indication extension for Gadovist, involved 138 children and adolescents who were scheduled for a contrast-enhanced MRT scan. The study investigated the pharmacokinetics (distribution and excretion) as well as the safety and tolerability of Gadovist in young patients. It also undertook an assessment of imaging quality. It was shown that Gadovist is well-tolerated in this patient group too. The study also confirmed that the dosage recommendation based on body weight, which is routine in adults, is also appropriate for the use of Gadovist in children.
About Gadovist
Gadovist is a modern macrocyclic, highly efficient MRT contrast agent. It is approved for the contrast-enhanced MRT of various parts of the body, including the brain, the spinal chord, the liver, the kidney and the blood-vessel system. With its 1.0 mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market. Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per mL of all gadolinium based contrast media. This results in excellent image quality and offers practical advantages, like smaller injection volumes. Gadovist was approved for the first time in 1998 and is now approved in over 80 countries.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at .
.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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