Ireland - English - HPRA (Health Products Regulatory Authority)

valeas spa industria chimica e farmaceutica - salbutamol - pressurised inhalation, suspension - 100 microgram(s) - selective beta-2-adrenoreceptor agonists; salbutamol

Australia - English - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - follitropin alfa, quantity: 300 iu - injection, solution - excipient ingredients: polysorbate 20; water for injections; sodium hydroxide; benzalkonium chloride; benzyl alcohol; mannitol; methionine; monobasic sodium phosphate dihydrate - 1. the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.,2. for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.,3. ovaleap is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - follitropin alfa, quantity: 900 iu - injection, solution - excipient ingredients: polysorbate 20; benzalkonium chloride; sodium hydroxide; water for injections; benzyl alcohol; mannitol; methionine; monobasic sodium phosphate dihydrate - 1. the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.,2. for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.,3. ovaleap is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Australia - English - Department of Health (Therapeutic Goods Administration)

theramex australia pty ltd - follitropin alfa, quantity: 450 iu - injection, solution - excipient ingredients: benzalkonium chloride; benzyl alcohol; mannitol; water for injections; methionine; polysorbate 20; sodium hydroxide; monobasic sodium phosphate dihydrate - 1. the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.,2. for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.,3. ovaleap is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

European Union - English - EMA (European Medicines Agency)

theramex ireland limited - follitropin alfa - anovulation - sex hormones and modulators of the genital system, - in adult womenanovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate;stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer and zygote intra-fallopian transfer;ovaleap in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. in clinical trials these patients were defined by an endogenous serum lh level < 1.2 iu/l.in adult menovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hcg) therapy.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

theramex hq uk ltd - follitropin alfa - solution for injection - 600unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

theramex hq uk ltd - follitropin alfa - solution for injection - 600unit/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

theramex hq uk ltd - follitropin alfa - solution for injection - 600unit/1ml

Israel - English - Ministry of Health

truemed ltd, israel - follitropin alfa - solution for injection - follitropin alfa 600 iu / 1 ml - follitropin alfa - in adult women:• anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.• stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra fallopian transfer (zift).• ovaleap in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. in clinical trials these patients were defined by an endogenous serum lh level < 1.2 iu/l.in adult men:• ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hcg) therapy.