Australija - engleski - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - idelalisib, quantity: 150 mg - tablet, film coated - excipient ingredients: hyprolose; sodium starch glycollate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - idelalisib, quantity: 100 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; microcrystalline cellulose; hyprolose; magnesium stearate; croscarmellose sodium; titanium dioxide; sunset yellow fcf aluminium lake; purified talc; polyvinyl alcohol; macrogol 3350 - ? zydelig in combination with rituximab is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (cll)/small lymphocytic lymphoma (sll) upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig in combination with ofatumumab is indicated for the treatment of adult patients with cll/sll upon relapse in patients for whom chemo-immunotherapy is not considered suitable. ? zydelig is indicated as monotherapy for the treatment of patients with follicular lymphoma which is refractory to at least two prior systemic therapies. the disease must be refractory to both rituximab and an alkylating agent.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - vantas is indicated for the palliative treatment of advanced prostate cancer. vantas is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs. risk summary the safety and efficacy of vantas have not been established in females. based on findings in animal studies and its mechanism of action, vantas can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . expected hormonal changes that occur with vantas treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. in animal reproduction studies, administration of histrelin to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures (see data) . advise pregnant patients and females of reproductive potential of the potential risk to the fetus. d

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - nafarelin acetate (unii: 8enz0qjw4h) (nafarelin - unii:1x0094v6jv) - nafarelin 2 mg in 1 ml - (for endometriosis, see reverse side ) synarel is indicated for treatment of central precocious puberty (cpp) (gonadotropin-dependent precocious puberty) in children of both sexes. the diagnosis of central precocious puberty (cpp) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. the diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal lh response to stimulation by native gnrh. pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. magnetic resonance imaging or ct-scanning of the brain is recommended to detect hypothalamic or pituitary tumors, or anatomical changes associated with increased intracranial pressure. other causes of sexual precocity, such as congenital adrenal hyperplasia, testotoxicosis, testicular

Europska Unija - engleski - EMA (European Medicines Agency)

eli lilly nederland b.v. - duloxetine - anxiety disorders; diabetic neuropathies; depressive disorder, major - psychoanaleptics, - treatment of major depressive disorder.treatment of diabetic peripheral neuropathic pain.treatment of generalised anxiety disorder.cymbalta is indicated in adults.

Europska Unija - engleski - EMA (European Medicines Agency)

eli lilly nederland b.v. - olaratumab - sarcoma - antineoplastic agents - lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin (see section 5.1).

Europska Unija - engleski - EMA (European Medicines Agency)

eli lilly nederland b.v. - duloxetine hydrochloride - urinary incontinence, stress - psychoanaleptics, - yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (sui).

Europska Unija - engleski - EMA (European Medicines Agency)

eli lilly nederland b.v. - raloxifene hydrochloride - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. a significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. when determining the choice of optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Europska Unija - engleski - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - breast neoplasms - antineoplastic agents - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5.1).in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Europska Unija - engleski - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - antineoplastic agents - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.