Grifols obtains EMA license to market its Flebogamma® DIF at 10% concentration


15.12.2010

Grifols obtains European Medicines Agency (EMA) license to market intravenous immunoglobulin (IVIG) at 10% concentration (Flebogamma® DIF 100 mg/ml). This approval arrives immediately after sales of this product have started in the United States.

Flebogamma® DIF 100 mg/ml is an IVIG at 10% concentration, allowing Grifols to offer two concentrations of the product in Europe (5% and 10%), both ready for administration. It will gradually be made available in all European Union countries, enabling Grifols to better attend to the needs of European health professionals and patients. The group began the sale of Flebogamma® DIF 50 mg/ml (5% concentration) in Europe in 2008.

This new immunoglobulin solution at 10% complies with the highest quality standards which Grifols applies to all its products. The manufacturing process patented by the company and developed at its Barcelona plant incorporates two different pathogen inactivation processes, in addition to a 20 nanometer filtration stage, which significantly increases the safety margins of Flebogamma® DIF 100 mg/ml, making it possible to obtain a high purity solution.

About Flebogamma® DIF

Flebogamma® DIF is a stable, polyvalent IVIG which can be stored at room temperature (≤ 30ºC) for up to two years, as a result of which no refrigeration is required during the product lifetime. This facilitates logistics, distribution and use of the product.

Grifols´commitment to quality and safety of all its plasma derivatives is enhanced by using the very latest technology to guarantee the traceability of its products. As a result, each vial of Flebogamma® DIF is laser marked to ensure its authenticity, and each container includes a holographic seal on the opening flap.

In addition, Grifols gives its customers access to information about the origin of the plasma, analysis performed, and the characteristics of each product batch through its PediGri® website (www.pedigri.grifols.com). This is an exclusive service offered by Grifols to prescribing physicians, and it reflects the company's commitment to providing transparent information about the traceability and quality of its plasma products.

Flebogamma® DIF is especially indicated for replacement treatment in primary and secondary immunodeficiencies, and for immunomodulatory treatment in autoimmune diseases and allogenic bone marrow transplant.

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