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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.

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.

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.

Chemical substance
Description
Choriogonadotropin alpha

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
Methionine
Poloxamer 188
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.

Marketing authorization holder
Authorization dates

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

Marketing authorization number:

EU/1/00/165/007