Ireland - English - HPRA (Health Products Regulatory Authority)

besins healthcare ireland limited - testosterone undecanoate - solution for injection - testosterone

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

amneal pharmaceuticals of new york llc - methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - methyltestosterone 10 mg - 1. males androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenita or acquired) — testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. - hypogonadotropic hypogonadism (congenital or acquired) — gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. safety and efficacy of methyltestosterone in men

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

stat rx usa - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 50 mg in 5 g - testim® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum levels but have gonadotropins in the normal or low range. testim® has not been clinically evaluated in males under 18 years of age. androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. testim® is

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

actavis pharma, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 2 mg in 1 d - androderm is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism,  bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use - safety and efficacy of androderm in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of andro

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

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg - striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. these patients have low serum testosterone levels but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of striant in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety a

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

columbia laboratories, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg - striant® is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (fsh, lh) above the normal range. hypogonadotropic hypogonadism (congenital or acquired) -- idiopathic gonadotropin or lhrh deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. these patients have low serum testosterone levels but have gonadotropins in the normal or low range. androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. striant® is not indicated for use in women, and must not be used in women. testosterone supplements may cause fetal harm. striant® should not be use

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

rebel distributors corp. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 1 g - 1.1 testosterone replacement therapy androgel, an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum levels but have gonadotropins in the normal or low range. androgel should not be used in any of the following patients: - men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precaution

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

physicians total care, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 10 mg in 1 g - androgel, an androgen, is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired) - idiopathic gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum levels but have gonadotropins in the normal or low range. androgel should not be used in any of the following patients: - men with carcinoma of the breast or known or suspected carcinoma of the prostate [see warnings and precautions (5.1), adverse reactions (6.1), and

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

allergan, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 2 mg in 1 d - androderm is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism,  bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (fsh, lh) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use - safety and efficacy of androderm in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety and efficacy of andro

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

aytu bioscience, inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 5.5 mg - natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. - primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. these men have low testosterone serum concentrations but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of natesto in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not b