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Merck Serono Receives European Approval for Three Pre-filled, Ready-To-Use Pen Injectors for Fertility Treatment

By Pharmaceutical Processing | July 5, 2011

 

Merck Serono, a division of Merck KGaA, Darmstadt, Germany,
has 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 at Merck Serono. ”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 needed1,2.

With a complete portfolio of gonadotropins, Merck Serono
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 help from in-vitro fertilization techniques3.
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.

 

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