The MHRA granted IBSA Farmaceutici Italia Srl a Marketing Authorisation for the medicinal product
Merional sc 75 IU/150 IU, powder and solvent for solution for injection (PL 21039/0016 & 0017) on 2
August 2011. This medicine is subject to restrict
ed medical prescription and is indicated for the
treatment of anovulation (including polycystic
ovarian disease, PCOD) in women who have been
unresponsive to treatment with chlomiphene citrate and
stimulation of multifollicular development in
patients undergoing assisted reproductive technologies (ART) such as
gamete intrafallopian transfer (GIFT) and zygote intrafallopian transfer (ZIFT). Merional 75 IU/150 IU
may be given in combination with human chorionic gonadotrophin (hCG) for the stimulation of
spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism.
Merional contains menotrophin (human menopausal gonadotrophin) as an active ingredient and is a
blend of follicle stimulating hormone (FSH) and luteiniz
ing hormone (LH) to the ratio of 1:1 of FSH:LH
activity plus small amounts of human chorioni
c gonadotrophin (hCG). Human chorionic gonadotrophin
is added to supplement the LH activity. In women, LH stimulates oestrogen and progesterone
production from the ovary. In men, LH stimulates test
osterone production from the interstitial cells of
the testes (Leydig cells).
Merional sc is a sterile, lyophilised powder of highly purified menotrophin (human menopausal
gonadotrophin) intended for injection after reconstitution with sterile 0.9% sodium chloride solution.
The formulation of the lyophilised drug product contains
lactose monohydrate as the sole excipient.
A critical review of the clinical and pharmaceutical data presented to the MHRA demonstrated that
Merional is effective in the treatment of anovulation.