Izrael - angol - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - nafarelin acetate - nasal solution - nafarelin acetate 2 mg/ml - nafarelin - - controlled ovarian stimulation programmes prior to in-vitro fertilisation.- hormonal management of endometriosis, including pain relief and reduction of endometrial lesions. - uterine fibroids.

Egyesült Államok - angol - NLM (National Library of Medicine)

ax pharmaceutical corp - histrelin acetate (unii: qmg7hld1ze) (histrelin acetate - unii:qmg7hld1ze) - histrelin acetate .99 g in 1 g

Egyesült Államok - angol - NLM (National Library of Medicine)

attix pharmaceuticals - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) -

Egyesült Államok - angol - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - tremelimumab (unii: qen1x95cix) (tremelimumab - unii:qen1x95cix) - imjudo, in combination with durvalumab, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc). imjudo, in combination with durvalumab and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic nsclc with no sensitizing epidermal growth factor receptor (egfr) mutations or anaplastic lymphoma kinase (alk) genomic tumor aberrations. none. risk summary based on findings from animal studies and its mechanism of action, imjudo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of imjudo in pregnant women. in animal studies, ctla-4 blockade is associated with increased risk of immune-mediated rejection of the developing fetus and fetal death (see data ). human immunoglobulin g2 (igg2) is known to cross the placental barrier; therefore, imjudo has the potential to be transmitted from the mother to the developing fetus. advise pregnant women and females of reproductive potential of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in a reproduction study, administration of tremelimumab-actl to pregnant cynomolgus monkeys during the period of organogenesis was not associated with maternal toxicity or effects on embryo-fetal development at exposure levels approximately 4 to 31-times higher than those observed at a recommended dose range of 75 mg to 300 mg based on area under the curve (auc). ctla-4 plays a role in maintaining maternal immune tolerance to the fetus to preserve pregnancy and in immune regulation of the newborn. in a murine model of pregnancy, ctla-4 blockade resulted in increased resorptions and reduced live fetuses. mated genetically engineered mice heterozygous for ctla-4 (ctla-4+/-) gave birth to ctla-4+/- offspring and offspring deficient in ctla-4 (homozygous negative, ctla-4-/-) that appeared healthy at birth. the ctla-4-/- homozygous negative offspring developed signs of a lymphoproliferative disorder and died by 3 to 4 weeks of age with multiorgan tissue destruction. based on its mechanism of action, fetal exposure to tremelimumab-actl may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there are no data on the presence of tremelimumab-actl in human milk, its effects on a breastfed child, or on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to imjudo are unknown. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with imjudo and for 3 months after the last dose. refer to the prescribing information for agents administered in combination with imjudo for breastfeeding recommendations, as appropriate. imjudo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating treatment with imjudo. contraception advise females of reproductive potential to use effective contraception during treatment with imjudo and for 3 months after the last dose. refer to the prescribing information for the agents administered in combination with imjudo for recommended contraception duration, as appropriate. the safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. of the 393 patients with uhcc treated with imjudo in combination with durvalumab, 50% of patients were 65 years or older and 13% of patients were 75 years or older. no overall differences in safety or efficacy of imjudo have been observed between patients 65 years or older and younger adult patients. of the 330 patients with metastatic nsclc treated with imjudo in combination with durvalumab and platinum-based chemotherapy, 143 (43%) patients were 65 years or older and 35 (11%) patients were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Egyesült Államok - angol - NLM (National Library of Medicine)

zhejiang peptites biotech co., ltd - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) -

Japán - angol - すりの適正使用協議会 RAD-AR Council, Japan

fuji pharmaceutical co.,ltd. - nafarelin acetate hydrate - limpid and colorless nasal solution

Írország - angol - HPRA (Health Products Regulatory Authority)

eli lilly and company limited - insulin human - suspension for injection - 100 iu/ml - insulin (human)

Írország - angol - HPRA (Health Products Regulatory Authority)

eli lilly and company limited - insulin human - solution for injection - 100 iu/ml - insulins and analogues for injection, fast-acting

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - abciximab -

Írország - angol - HPRA (Health Products Regulatory Authority)

eli lilly and company limited - insulin human - solution for injection - 100 iu/ml - insulins and analogues for injection, fast-acting