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news.Gonal-f is intended to be used for ovulation induction in infertile women
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German Merck has received approval from Japanese Ministry of Health, Labor and Welfare to extend indication of Gonal-f (follitropin alfa for injection). It is for infertile women suffering from irregular or no ovulation (oligoovulation or anovulation), due to a dysfunction in the hypothalamic-pituitary system or polycystic ovarian syndrome.
The extended marketing authorization includes Gonal-f in 75 IU vial and Gonal-f prefilled pen in 300 IU, 450 IU and 900 IU.
Franck Latrille, executive vice president, Commercial International at Merck’s division-Merck Serono, said: “Today in Japan, it is estimated that one in 10 couples suffer from infertility. With the fast approval of Gonal-f for infertile female patients, we are pleased to provide Japanese women access to the leading infertility treatment.”
“To increase choice and convenience for patients, Gonal-f will be available in several strengths and formats including ready to use prefilled pens for injection,” he added.