Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Luveris 75 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection (powder for injection). Appearance of the powder: white lyophilised pellet Appearance of the solvent: clear colourless solution The pH of the reconstituted solution is 7.5 to 8.5. |
One vial contains 75 IU of lutropin alfa*.
* recombinant human luteinising hormone (r-hLH) produced in genetically engineered Chinese hamster ovary (CHO) cells by recombinant DNA technology
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH). Luteinising hormone (LH) and follicle stimulating hormone (FSH) are secreted from the anterior pituitary gland in response to gonadotropin-releasing hormone (GnRH) and play a complementary role in follicle development and ovulation. In theca cells, LH stimulates the secretion of androgens that are transferred to granulosa cells to be converted to estradiol (E2) by aromatase. In granulosa cells, FSH stimulates the development of ovarian follicles, while LH action is involved in follicle development, steroidogenesis and maturation. |
| List of Excipients |
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Powder: Sucrose Solvent: Water for injection |
The powder is packaged in 3 mL neutral colourless glass (type I) vials. The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps. The solvent is packaged in 2 or 3 mL neutral colourless glass (type I) vials with a Teflon-coated rubber stopper.
Packs of 1, 3 or 10 vials with the corresponding number of solvent vials. Not all pack sizes may be marketed.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/00/155/004
EU/1/00/155/005
EU/1/00/155/006
Date of first authorisation: 29 November 2000
Date of latest renewal: 24 January 2006
| Drug | Countries | |
|---|---|---|
| LUVERIS | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa |
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