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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - follitropin alfa 225 [iu] (16.5 mcg) - solution for injection - 600 iu/ml - active: follitropin alfa 225 [iu] (16.5 mcg) excipient: dibasic sodium phosphate dihydrate methionine monobasic sodium phosphate dihydrate phosphoric acid poloxamer sucrose water for injection - in adult men: bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Israel - English - Ministry of Health

merck serono ltd - follitropin alfa - powder for solution for injection - follitropin alfa 5.5 mcg/dose - follitropin alfa - follitropin alfa - 1) gonal-f followed by chorionic gonadotrophin (hcg) is recommended for the stimulation of follicular development and ovulation in women with hypothalamic-pituitary dysfunction who present with either oligomenorrhoea or amenorrhoea. these women are classified as w.h.o group ii patients and usually receive clomiphene citrate as primary therapy. they have evidence of endogenous oestrogen production and thus will either spontaneously menstruate or experience withdrawal bleeding after progestagen administration. polycystic ovarian disease (pcod) is part of the who ii classification and is present in the majority of these patients. 2) gonal-f is indicated for stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertillization (ivf) gamete intra-fallopian transfer (gift) and zogote intra-fallopian transfer (zift). 3) gonal-f is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism.

Israel - English - Ministry of Health

merck serono ltd - follitropin alfa; lutropin alfa - powder and solvent for solution for injection - follitropin alfa 150 iu; lutropin alfa 75 iu - follitropin alfa - follitropin alfa - pergoveris is indicated 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.

Israel - English - Ministry of Health

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

European Union - English - EMA (European Medicines Agency)

gedeon richter plc. - follitropin alfa - anovulation - sex hormones and modulators of the genital system, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa 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:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.

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

gedeon richter australia pty ltd - follitropin alfa, quantity: 450 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- afolia is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- afolia 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:,- afolia 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)

gedeon richter australia pty ltd - follitropin alfa, quantity: 150 iu - injection, solution - excipient ingredients: poloxamer; sucrose; dibasic sodium phosphate dihydrate; monobasic sodium phosphate dihydrate; methionine; phosphoric acid; thymidine; trypsin - in adult women:,- afolia is indicated for the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated,- controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies,- afolia 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:,- afolia is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.