Euroopan unioni - englanti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease virus, serotype 1, strain rn1250; live recombinant turkey herpesvirus, expressing the vp2 protein of infectious bursal disease virus, strain vhvt013-69 - immunologicals for aves, domestic fowl, avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus - chicken - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus), and to prevent mortality, clinical signs and lesions caused by infectious bursal disease (ibd) virus.

Euroopan unioni - englanti - EMA (European Medicines Agency)

csl behring gmbh - etranacogene dezaparvovec - hemophilia b - other hematological agents - treatment of severe and moderately severe haemophilia b (congenital factor ix deficiency) in adult patients without a history of factor ix inhibitors.

Yhdysvallat - englanti - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - exagamglogene autotemcel (unii: s53l777gm8) (exagamglogene autotemcel - unii:s53l777gm8) - casgevy is indicated for the treatment of patients aged 12 years and older with: - sickle cell disease (scd) with recurrent vaso-occlusive crises - transfusion-dependent β- thalassemia (tdt) none. consider the risks of mobilization and myeloablative conditioning agents in patients with reproductive potential and patients that are pregnant or breastfeeding. risk summary there are no clinical data from the use of exagamglogene autotemcel in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with exagamglogene autotemcel to assess whether it can cause fetal harm when administered to a pregnant woman. casgevy must not be administered during pregnancy because of the risks associated with myeloablative conditioning. pregnancy after casgevy infusion should be discussed with the treating physician. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there are no data on the presence of exagamglogene autotemcel in human or animal milk, the effects on the breastfed child, or the effects on milk production. because of the potential risks associated with myeloablative conditioning, breastfeeding should be discontinued during conditioning. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for casgevy and any potential adverse effects on the breastfed child from casgevy or from the underlying maternal condition. breastfeeding after casgevy infusion should be discussed with the treating physician. pregnancy testing a negative serum pregnancy test must be confirmed prior to the start of each mobilization cycle and re-confirmed prior to myeloablative conditioning. contraception there are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with casgevy. women of childbearing potential and men capable of fathering a child should use effective method of contraception from start of mobilization through at least 6 months after administration of casgevy. advise patients of the risks associated with conditioning agents. infertility there are no data on the effects of exagamglogene autotemcel on human fertility. effects on male and female fertility have not been evaluated in animal studies. infertility has been observed with myeloablative conditioning therefore, advise patients of fertility preservation options before treatment, if appropriate. the safety and efficacy of casgevy has been established in pediatric patients with scd and tdt aged 12 years and older. use of casgevy in patients aged 12 to less than 18 years is supported by data in 12 patients with scd in trial 1 (6 patients evaluable for the primary efficacy analysis), and 18 patients with tdt in trial 2 (11 patients evaluable for the primary efficacy analysis). the efficacy and safety profile of casgevy in pediatric patients aged 12 years and older were consistent with the efficacy and safety in adult patients [see adverse reactions (6.1) and clinical studies (14.1, 14.2)] . patients with scd the median (min, max) time to platelet engraftment was 45 (23, 81) days in pediatric patients aged 12 years and older and 32 (23, 126) days in adult patients. the median (min, max) time to neutrophil engraftment was 28 (24, 40) days in pediatric patients aged 12 years and older and 26 (15, 38) days in adult patients. patients with tdt the median (min, max) time to platelet engraftment was 45 (20, 199) days in pediatric patients aged 12 years and older and 41.5 (24, 200) days in adult patients. the median (min, max) time to neutrophil engraftment was 30 (19, 56) days in pediatric patients aged 12 years and older and 28.5 (12, 40) days in adult patients. the safety and efficacy of casgevy in pediatric patients aged less than 12 years has not been established. casgevy has not been studied in patients > 65 years of age. hsc transplantation must be appropriate for a patient to be treated with casgevy. casgevy has not been studied in patients with renal impairment, defined as estimated glomerular filtration rate < 60 ml/min/1.73 m2 . patients should be assessed for renal impairment to ensure hsc transplantation is appropriate. casgevy has not been studied in patients with hepatic impairment. patients should be assessed for hepatic impairment to ensure hsc transplantation is appropriate. casgevy has not been studied in patients with hiv-1, hiv-2, hbv or hcv. perform screening for hiv-1, hiv-2, hbv and hcv and any other infectious agents in accordance with local guidelines before collection of cells for manufacturing. casgevy should not be used in patients with active hiv-1, hiv-2, hbv or hcv. casgevy has not been studied in patients who have received a prior allogeneic or autologous hsc transplant. treatment with casgevy is not recommended in these patients.

Malesia - englanti - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius medical care malaysia sdn bhd - calcium chloride dihydrate; sodium chloride.; magnesium chloride (hexahydrate); glucose monohydrate; sodium lactate solution -

Armenia - englanti - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

glaxo wellcome s.a. - eltrombopag (eltrombopag olamine) - tablets film-coated - 25mg