European Commission approves Gonal-f Filled-by-Mass prefilled pen.

2004 APR 1 - (NewsRx.com & NewsRx.net) -- Serono (SEO, SRA) announced that the European Commission has approved its Gonal-f Filled-by-Mass solution for injection in a pre-filled pen, which delivers the company's market-leading recombinant human follicle-stimulating hormone.

"As the worldwide leader in infertility treatment, Serono is committed to developing innovative products," said Ernesto Bertarelli, CEO of Serono. "The Gonal-f (FbM) Prefilled Pen delivers the most consistent FSH in the only ready-to-use pre-filled pen available on the market."

To make infertility treatment easier and more accurate for patients, the new Gonal-f (FbM) Prefilled Pen is specifically designed for infertility treatment and will be available in 3 multidose presentations; 300 IU/0.5 ml (22 micron g/0.5 ml), 450 IU/0.75 ml (33 micron g/0.75 ml) and 900 IU/1.5 ml (66 micron g/1.5 ml).

"This is the first ready-to-use pen that enables us to combine the efficacy of the most consistent FSH with the flexibility to individualize the dosing in ovulation induction and Assisted Reproductive Techniques for each patient," said professor Christoph Keck, MD, from the Department of Obstetrics and Gynecology of the University of Freiburg, Germany. "Having Gonal-f (FbM) in a pre-filled, ready-to-use pen will make the administration easier for the patients, and help them to ensure that they have injected the right dose."

The Gonal-f (FbM) Prefilled Pen will continue to carry the same indications as the currently marketed product for a) anovulation in women who have been unresponsive to treatment with ...