Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringe. Clear, colourless to slightly yellow solution. The pH of the solution is 7.0 ± 0.3, its osmolality 250-400 mOsm/kg. |
Each pre-filled syringe contains 250 micrograms choriogonadotropin alfa* (equivalent to approximately 6,500 IU) in 0.5 mL solution.
* recombinant human chorionic gonadotropin, r-hCG produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum. |
| List of Excipients |
|---|
|
Mannitol |
0.5 mL of solution in a pre-filled syringe (type I glass) with a plunger stopper (halobutyl rubber) and plunger (plastic), and with a needle for injection (stainless) – pack of 1.
Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
EU/1/00/165/007
Date of first authorisation: 02 February 2001
Date of latest renewal: 02 February 2006
| Drug | Countries | |
|---|---|---|
| OVITRELLE | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom |
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