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 -

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.

Canada - English - Health Canada

ferring inc - follitropin delta - solution - 12mcg - follitropin delta 12mcg - gonadotropins and antigonadotropins

Canada - English - Health Canada

ferring inc - follitropin delta - solution - 36mcg - follitropin delta 36mcg - gonadotropins and antigonadotropins

Canada - English - Health Canada

ferring inc - follitropin delta - solution - 72mcg - follitropin delta 72mcg - gonadotropins and antigonadotropins

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

merck healthcare pty ltd - follitropin alfa, quantity: 600 iu/ml - injection, powder for - excipient ingredients: dibasic sodium phosphate dihydrate; sodium hydroxide; sucrose; phosphoric acid; monobasic sodium phosphate - the treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated. for controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies. gonal-f is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

Ireland - English - HPRA (Health Products Regulatory Authority)

ferring ireland ltd - urofollitropin - pdr+solv for soln for inj - 75 international unit - urofollitropin

United States - English - NLM (National Library of Medicine)

organon llc - follitropin (unii: 076whw89tw) (follitropin - unii:076whw89tw) - follistim® aq cartridge (follitropin beta) injection, is indicated: in women for: prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation. - primary ovarian failure should be excluded. - the possibility of pregnancy should be excluded. - tubal patency should be demonstrated. - the fertility status of the male partner should be evaluated. prior to initiation of treatment with follistim aq cartridge: - women should have a complete gynecologic and endocrinologic evaluation and diagnosis of cause of infertility. - the possibility of pregnancy should be excluded. - the fertility status of the male partner should be evaluated. in men for: prior to initiation of treatment with follistim aq cartridge: - men should have a complete medical and endocrinologic evaluation. - hypogonadotropic hypogonadism should be confirmed and primary testicular failure should be excluded. - serum testosterone levels should be normalized with human chorionic gonadotropin (hcg) treatment. - the fertility status of the female partner should be evaluated. follistim aq cartridge is contraindicated in women and men who exhibit: - prior hypersensitivity to recombinant hfsh products - high levels of fsh indicating primary gonadal failure - presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see indications and usage (1.1, 1.2, 1.3)] - hypersensitivity reactions to streptomycin or neomycin. follistim aq may contain traces of these antibiotics - tumors of the ovary, breast, uterus, testis, hypothalamus or pituitary gland follistim aq cartridge is also contraindicated in women who exhibit: - pregnancy [see use in specific populations (8.1)] - heavy or irregular vaginal bleeding of undetermined origin - ovarian cysts or enlargement not due to polycystic ovary syndrome (pcos) risk summary follistim aq cartridge is contraindicated for use in pregnant women and offers no benefit during pregnancy. risk summary it is not known whether this drug is excreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for follistim aq cartridge and any potential adverse effects on the breastfed child from follistim aq cartridge or from the underlying maternal condition. follistim aq cartridge is not indicated for use in pediatric patients. clinical studies have not been conducted in the pediatric population. clinical studies of follistim aq cartridge have not been conducted in patients 65 years of age and older.