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

organon pharma pty ltd - follitropin beta, quantity: 833 iu/ml - injection, solution - excipient ingredients: sucrose; sodium citrate dihydrate; polysorbate 20; benzyl alcohol; methionine; hydrochloric acid; sodium hydroxide; water for injections - in the female: anovulatory infertility and; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in vitro fertilisation and related procedures). in the male: for the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.

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

ferring pharmaceuticals pty ltd - follitropin delta -

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

ferring pharmaceuticals pty ltd - follitropin delta -

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

ferring pharmaceuticals pty ltd - follitropin delta -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bsv bioscience malaysia sdn. bhd. - urofollitropin -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

bsv bioscience malaysia sdn. bhd. - urofollitropin -

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.

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

gedeon richter australia pty ltd - follitropin alfa, quantity: 75 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.