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| Merck Received European Approval for Pen Injectors for Fertility Treatment |
Merck KGaA announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This "family of pens" is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f® (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris® (lutropin alfa) 450 IU and Ovidrel®/Ovitrelle® 250 micrograms (choriogonadotropin alfa).
"Merck Serono is continuously working on improving its administration devices in order to meet patients' and healthcare professionals' needs," said Dr. Bharat Tewarie, Senior Vice President Global Business Unit Fertility and Metabolic Endocrinology of the Merck Serono division. "Fertility treatment specialists were involved from the beginning in the development of the new devices for the Merck Serono gonadotropins portfolio for fertility treatment. We are pleased to introduce today the specially designed injection devices that combine key features recommended by them." The newly approved prefilled pens were designed to facilitate daily administration by patients during their fertility treatment. The pens immediately confirm that a complete dose was delivered, or indicate the missing amount if an incomplete dose is injected. Other key features include a new graduated scale on reservoir for patients to check the amount of medication remaining in the pen and a bi-directional dose dial allowing them to correct the dose dialed, if needed(1,2). With a complete portfolio of gonadotropins, Merck offers fertility specialists the ability to tailor treatment to patients’ needs. Since the birth of the first IVF baby, nearly 4.3 million babies worldwide have been born with the help of in-vitro fertilization techniques(3). Merck Serono has helped thousands of infertile couples to realize their dream of becoming parents, and continues to seek new solutions that meet patients' treatment needs. The New Gonal-f prefilled pens are approved and launched in Australia, New Zealand, Canada and Switzerland, and are approved in Europe. Ovidrel/Ovitrelle prefilled pen is approved in Australia, New Zealand and Europe. Luveris prefilled pen is approved in Australia, Canada and Europe.
About Merck and Fertility Treatment
About Gonal-f Gonal-f has been approved in 100 countries worldwide - among which 74 countries have approved Gonal-f prefilled pen - including Europe and the US with indications of stimulation of the growth of ovarian follicles and ovulation in women. It is the most widely prescribed gonadotropin in the world. For males, Gonal-f has been approved in 77 countries worldwide, including Japan, for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In certain markets where Gonal-f is approved for this indication, the therapy needs to be in combination with human Chorionic Gonadotropin (hCG). In the US, Gonal-f Multi-Dose, available as the Gonal-f 1050 IU vial or Gonal-f 450 IU vial is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure as well as for ovulation induction and the development of multiple follicles in the ovulatory female patient participating in an Assisted Reproductive Technology (ART). Gonal-f RFF Pen and 75 IU vial is approved for women only in the US.
About Luveris
About Ovitrelle/Ovidrel
About Merck KGaA
1. Christen et al. Expert Opinion in Drug Delivery 2011. |




Merck KGaA announced that the European Commission (EC) has granted an approval for three pre-filled, ready-to-use pen injectors for fertility treatment. This "family of pens" is designed for self-administration of the liquid formulations of its three recombinant gonadotropins used in fertility treatments: Gonal-f® (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris® (lutropin alfa) 450 IU and Ovidrel®/Ovitrelle® 250 micrograms (choriogonadotropin alfa).
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