Pergoveris; follicle stimulating hormone alpha plus luteinizing hormone, recombinant; Gonal-F plus Luveris; FSH plus
Status: recently approved in European Union
Organizations involved:
Merck Serono S.A. – Manuf.; R&D; Tech.; Intl. mark.
EMD Serono, Inc. – USA mark.
Merck KGaA – Parent
Serono International S.A. – Former
Cross ref.: See the entries for the components of this combination product --Gonal-f (#156) and Luveris (#228).
Description: Pergoveris refers to aqueous and lyophilized (freeze-dried) formulations combining recombinant Chinese hamster ovary cell (CHO)-expressed human FSH (follitropin alfa 150IU), marketed as Gonal-f, and recombinant CHO-expressed human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection. [With the product just approved as this edition was being finalized, further information, e.g., EMEA EPAR documents and product inserts/labeling, were not yet available].
Pergoveris is the only infertility treatment to offer the benefits of recombinant FSH and LH in a single injection (administered subcutaneously)
Nomenclature; FSH plus LH, rDNA/Serono [BIO]; Pergoveris [TR]; follicle stimulating hormone alpha plus luteinizing hormone, recombinant [SY]; FSH plus LH, rDNA [SY]; LH plus FSH, rDNA [SY]; luteinizing hormone plus follicle stimulating hormone alpha, recombinant [SY]
Companies.: The components of Pergovis, Gonal-f and Luveris, and Pergovis were developed by Serono International S.A. In Jan. 2007, Merck KGaA acquired Serono, which was renamed Merck Serono S.A.
Status: Pergovis received European Union (EU) approval on June 27, 2007, with this likely including orphan designation.
Indications: [in EU] = stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Index Terms:
Companies involvement:
Full monograph
157 FSH plus LH, rDNA/Merck Serono
Nomenclature:
FSH plus LH, rDNA/Merck Serono [BIO]
Pergoveris [TR]
follicle stimulating hormone alpha plus luteinizing hormone, recombinant [SY]
FSH plus LH, rDNA [SY]
LH plus FSH, rDNA [SY]
luteinizing hormone plus follicle stimulating hormone alpha, recombinant [SY]
FDA Class: Biologic BLA
biopharmaceutical products
hamster source materials
murine (mouse) materials used
recombinant DNA
rodent source materials
lyophilized (freeze-dried)
North American coral snake
orphan status
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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