OVITRELLE Solution for injection in pre-filled syringe (2019)
Active ingredients: Choriogonadotropin alpha
Product Name and Form
Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe.
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.
Qualitative and Quantitative Composition
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.
Phosphoric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
Pack sizes and Marketing
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
Date of first authorisation: 02 February 2001
Date of latest renewal: 02 February 2006