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Merck Serono's Pergoveris Approved in EU
In late June, the European Commission granted marketing authorization for Merck Serono S.A.’s (Geneva, Switzerland, www.serono.com) Pergoveris, the first biologic intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.
In late June, the European Commission granted marketing authorization for Merck Serono S.A.’s (Geneva, Switzerland, www.serono.com) Pergoveris, the first biologic intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.
Pergoveris is the first product based on the combination of recombinant human FSH (r-hFSH or follitropin alfa 150IU) and recombinant human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection.
The marketing authorization applies to all 27 countries in the European Union (EU), as well as Iceland, Liechtenstein, and Norway. Launches of Pergoveris in the various countries of the EU will start in the third quarter of 2007.