Source: European Medicines Agency (EU) Revision Year: 2018 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. Appearance of the powder: white lyophilised pellet. Appearance of the solvent: clear colourless solution. The pH of the reconstituted solution is 7.5-8.5. Presentations other than ampoules should be considered for self administration by patients. |
One vial contains 75 IU of lutropin alfa (recombinant human Luteinising Hormone {r-hLH}). Lutropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lutropin alfa |
Lutropin alfa is a recombinant human Luteinising Hormone (r-hLH). Luteinising Hormone (LH) binds on the ovarian theca (and granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotropin hormone (hCG). Lutropin alfa in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH deficiency. |
| 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 either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules. Not all pack sizes may be marketed.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/00/155/001 (1 vial/1 ampoule)
EU/1/00/155/002 (3 vials/3 ampoules)
EU/1/00/155/003 (10 vials/10 ampoules)
EU/1/00/155/004 (1 vial/1 vial)
EU/1/00/155/005 (3 vial/3 vials)
EU/1/00/155/006 (10 vials/10 vials)
Date of first authorisation: 29th November 2000
Date of latest renewal: 30th November 2005
| 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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