Belpharma s.a. - search results

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

somatostatine-belpharma 3 mg inf. sol. (pwdr. + solv.) i.v. amp.

eumedica sa-nv - somatostatin 3 mg - powder and solvent for solution for infusion - 3 mg - somatostatin 3 mg - somatostatin

European Union - English - EMA (European Medicines Agency)

beromun

belpharma s.a. - tasonermin - sarcoma - immunostimulants, - beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft-tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic isolated-limb perfusion (ilp).

Ireland - English - HPRA (Health Products Regulatory Authority)

estreva gel 0.1 %w/w

belpharma sa - estradiol - gel - 0.1 %w/w

Ireland - English - HPRA (Health Products Regulatory Authority)

estreva 0.1 %w/w gel

belpharma sa - estradiol - gel - 0.1 %w/w

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

hyftor- sirolimus gel

nobelpharma america, llc - sirolimus (unii: w36zg6ft64) (sirolimus - unii:w36zg6ft64) - hyftor is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patients 6 years of age and older. hyftor is contraindicated in patients with a history of hypersensitivity to sirolimus or any other component of hyftor. reactions to sirolimus have included anaphylactic/anaphylactoid reactions, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis [see warning and precautions (5.1)] . risk summary based on animal studies and mechanism of action, oral sirolimus can cause fetal harm when administered to a pregnant woman. hyftor is systemically absorbed after topical administration and may result in fetal exposure. the available data from case reports on hyftor use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with hyftor. in an animal reproduction study, oral administration of 0.5 mg/kg/day sirolimus caused embryo-fetal lethality in pregnant rats when administered during the period of organogenesis (see data). the available data do not allow the calculation of relevant comparisons between the systemic exposure of sirolimus observed in animal studies to the systemic exposure that would be expected in humans after topical use of hyftor. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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 embryo-fetal development studies in rats, oral administration of sirolimus to pregnant rats during the period of organogenesis (gestation days 6 -15) induced embryo-fetal lethality at 0.5 mg/kg/day, reduced fetal body weight at 1.0 mg/kg/day and caused maternal toxicity at 2.0 mg/kg/day. no treatment related embryo-fetal developmental effects were observed at 0.1 mg/kg/day. in embryo-fetal development studies in rabbits, oral administration of sirolimus to pregnant rabbits during the period of organogenesis (gestation days 6 -18) induced maternal toxicity (decreased body weight) at 0.05 mg/kg/day, which was associated with embryo-fetal loss or early resorption. no treatment related developmental effects were observed at 0.025 mg/kg/day. in a pre- and postnatal development toxicity study, oral administration of sirolimus to pregnant rats during gestation and lactation (gestation day 6 through lactation day 20) increased the incidence of dead pups, resulting in reduced live litter size at 0.5 mg/kg/day. no treatment related developmental effects were observed at 0.1 mg/kg/day. sirolimus did not cause maternal toxicity or affect developmental parameters in the surviving offspring (morphological development, motor activity, learning, or fertility assessment) at 0.5 mg/kg/day, the highest dose tested. risk summary there are no available data on the presence of sirolimus in human milk, the effects on the breastfed infant, or the effects on milk production. after oral administration, sirolimus was present in the milk of lactating rats. because of the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment with hyftor. contraception based on animal studies with oral sirolimus, hyftor may cause fetal harm when administered to pregnant women. females of reproductive potential are recommended to avoid becoming pregnant and to use an effective contraceptive method. effective contraception should be initiated before hyftor therapy and used throughout treatment and for 12 weeks after the final dose of hyftor [see warnings and precautions (5.7), use in specific populations (8.1)] . infertility based on clinical findings and findings in animal studies, male and female fertility may be compromised by the treatment with sirolimus [see warnings and precautions (5.8), nonclinical toxicology (13.1)]. ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia) have been reported in females with the use of oral sirolimus. azoospermia has been reported in males with the use of oral sirolimus and have been reversible upon discontinuation of sirolimus in most cases. the safety and effectiveness of hyftor have been established in pediatric patients aged 6 years and older for the topical treatment of facial angiofibroma associated with tuberous sclerosis. use of hyftor in this age group is supported by data from a randomized, vehicle-controlled, double-blind 12-week trial along with additional efficacy and long-term safety data from a 104-week open label safety trial. a total of 13 pediatric subjects aged 6 years to 17 years received hyftor in the phase 3 clinical trial along with 48 pediatric subjects aged 3 years to 17 years in the 104-week open label safety trial. adverse reactions occurred with similar frequency in adult and pediatric subjects [see adverse reaction (6.1), clinical studies (14)]. the safety and effectiveness of hyftor for this indication have not been established in pediatric patients less than 6 years of age. clinical studies of hyftor did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.