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European approval for Merck Serono pre-filled pen injectors

The European Commission (EC) has given approval to Merck Serono's three pre-filled, ready-to-use pen injectors which offer specialists the ability to tailor fertility treatment to patients’ needs.

The prefilled pens are designed to facilitate daily administration of GONAL-f (follitropin alfa) 300 IU, 450 IU and 900 IU, Luveris (lutropin alfa) 450 IU and Ovidrel/ Ovitrelle 250 micrograms (choriogonadotropin alfa).

GONAL-f stimulates the ovaries and produce eggs in women and spermatogenesis induction in men.

Luveris is a recombinant human luteinising hormone (r-hLH) developed to support follicular growth in women with severe FSH and LH deficiency.

Ovitrelle/Ovidrel, a recombinant chorionic gonadotropin (r-hCG), is indicated to induce final follicular maturation and trigger ovulation in women with no ovulation, and to induce final follicular maturation for women undergoing ART, such as in-vitro fertilization..

The pens confirm that a complete dose was delivered, or indicate the missing amount if an incomplete dose is injected.

The pen injectors other 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.

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.