Grækenland - græsk - Εθνικός Οργανισμός Φαρμάκων

eusa pharma (netherlands) b.v., the netherlands johannes vermeerplein 11, 1071 dv amsterdam - dinutuximab beta - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 4,5 mg/ml - dinutuximab beta 4,5mg - dinutuximab

USA - engelsk - NLM (National Library of Medicine)

united therapeutics corporation - dinutuximab (unii: 7sqy4zud30) (dinutuximab - unii:7sqy4zud30) - dinutuximab 3.5 mg in 1 ml - unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and 13-cis-retinoic acid (ra), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see clinical studies (14)]. unituxin is contraindicated in patients with a history of anaphylaxis to dinutuximab. risk summary based on its mechanism of action, unituxin may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no studies in pregnant women and no reproductive studies in animals to inform the drug-associated risk. monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. risk summary there is no information available on the presence of dinutuximab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, human igg is present in human milk. because of the potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during treatment with unituxin. contraception females unituxin may cause fetal harm [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment and for 2 months after the last dose of unituxin. the safety and effectiveness of unituxin as part of multi-agent, multimodality therapy have been established in pediatric patients with high-risk neuroblastoma based on results of an open-label, randomized (1:1) trial conducted in 226 patients aged 11 months to 15 years (median age 3.8 years) (study 1). prior to enrollment, patients achieved at least a partial response to prior first-line therapy for high-risk neuroblastoma consisting of induction combination chemotherapy, maximum feasible surgical resection, myeloablative consolidation chemotherapy followed by autologous stem cell transplant, and received radiation therapy to residual soft tissue disease. patients randomized to the unituxin/13-cis-retinoic acid (ra) arm (unituxin/ra) received up to 5 cycles of unituxin in combination with alternating cycles of granulocyte-macrophage colony-stimulating factor (gm-csf) and interleukin-2 (il-2) plus ra, followed by 1 cycle of ra alone. patients randomized to the ra arm received up to 6 cycles of ra monotherapy. study 1 demonstrated an improvement in event-free survival (efs) and overall survival (os) in patients in the unituxin/ra arm compared to those in the ra arm [see adverse reactions (6), clinical pharmacology (12), and clinical studies (14)] . juvenile animal toxicity data juvenile monkeys (13 to 18 months of age at study start) received dinutuximab daily via intravenous infusion for 4 consecutive days over five 28-day cycles at doses of 1, 3, or 10 mg/kg. monkeys also received morphine during infusion for pain management. at the high dose of 10 mg/kg (approximately equal to the 17.5 mg/m2 clinical dose), mild degeneration of nerve fibers in the brain (medulla oblongata) and moderate degeneration of nerve fibers in the spinal cord (cervical, thoracic, and lumbar) were present. mild neuronal and nerve fiber degeneration were also present in the dorsal root ganglia (cervical, thoracic, and lumbar). nerve fiber degeneration in the spinal cord and neuronal degeneration in dorsal root ganglia persisted 6 months after the end of dosing, though at lower severity. at the 10 mg/kg dose level, nerve conduction velocity (ncv) analysis showed motor and sensory ncv decreases of less than 10% compared to vehicle controls, starting on day 27 and continuing to day 83. sensory ncv decreases were still present at the end of the dosing period but were on a trend towards recovery 6 months after the end of dosing. the safety and effectiveness of unituxin in geriatric patients have not been established. unituxin has not been studied in patients with renal impairment. unituxin has not been studied in patients with hepatic impairment.

Schweiz - italiensk - Swissmedic (Swiss Agency for Therapeutic Products)

medius ag - dinutuximabum beta - concentrato per soluzione per infusione - dinutuximabum beta 20.25 mg, saccharum, histidinum, polysorbatum 20, acidum hydrochloridum ad ph, aqua ad iniectabile q.s. ad solutionem pro 4.5 ml. - neuroblastoma - biotechnologika

Schweiz - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

medius ag - dinutuximabum beta - konzentrat zur herstellung einer infusionslösung - dinutuximabum beta 20.25 mg, saccharum, histidinum, polysorbatum 20, acidum hydrochloridum ad ph, aqua ad iniectabile q.s. ad solutionem pro 4.5 ml. - neuroblastoma - biotechnologika

Schweiz - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

medius ag - dinutuximabum beta - solution à diluer pour perfusion - dinutuximabum beta 20.25 mg, saccharum, histidinum, polysorbatum 20, acidum hydrochloridum ad ph, aqua ad iniectabile q.s. ad solutionem pro 4.5 ml. - neuroblastoma - biotechnologika

Rumænien - rumænsk - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

millmount healthcare ltd - irlanda - dinutuximab beta - conc. pt. sol. perf. - 4,5mg/ml - alte antineoplazice anticorpi monoclonali

Canada - fransk - Health Canada

united therapeutics corporation - dinutuximab - solution - 3.5mg - dinutuximab 3.5mg - antineoplastic agents

Canada - engelsk - Health Canada

united therapeutics corporation - dinutuximab - solution - 3.5mg - dinutuximab 3.5mg - antineoplastic agents

Den Europæiske Union - græsk - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - Νευροβλάστωμα - Αντινεοπλασματικοί παράγοντες - unituxin ενδείκνυται για τη θεραπεία της υψηλού κινδύνου Νευροβλάστωμα σε ασθενείς ηλικίας 12 μηνών έως 17 ετων, που έχουν προηγουμένως λάβει χημειοθεραπεία εφόδου και να επιτευχθεί τουλάχιστον μια μερική ανταπόκριση, ακολουθούμενη από τη μυελοαφανιστική θεραπεία και αυτόλογων βλαστικών κυττάρων μεταμόσχευση (asct). Χορηγείται σε συνδυασμό με παράγοντα διέγερσης αποικιών κοκκιοκυττάρων-μακροφάγων (gm-csf), ιντερλευκίνης-2 (il-2) και ισοτρετινοΐνη.

Storbritannien - engelsk - MHRA (Medicines & Healthcare Products Regulatory Agency)

eusa pharma ltd - dinutuximab beta - solution for infusion - 4.5mg/1ml