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

glaxo operations uk ltd - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - melphalan 50 mg in 10 ml

Velika Britanija - engleski - MHRA (Medicines & Healthcare Products Regulatory Agency)

aspen pharma trading ltd - melphalan - oral tablet - 2mg

Singapur - engleski - HSA (Health Sciences Authority)

dch auriga singapore - melphalan - injection - 50 mg/vial - melphalan 50 mg/vial

Irska - engleski - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - melphalan - powder and solvent for solution for infusion - 50 milligram(s) - nitrogen mustard analogues; melphalan

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

acrotech biopharma inc - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology (12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology (13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data   animal data adequate ani

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

cenexi - bla - melphalan hydrochloride (unii: 1vxp4v453t) (melphalan - unii:q41or9510p) - evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. history of serious allergic reaction to melphalan. risk summary based on its mechanism of action, evomela can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality [see clinical pharmacology ( 12.1)] . melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see nonclinical toxicology ( 13.1)] . in animal studies, melphalan was embryolethal and teratogenic in rats at doses below the recommended clinical doses [see data] . advise a pregnant woman of the potential risk to a fetus.. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth def

Novi Zeland - engleski - Medsafe (Medicines Safety Authority)

luminarie group limited - melphalan hydrochloride 11.1946 mg/ml equivalent to melphalan 10 mg - powder for injection - 50 mg - active: melphalan hydrochloride 11.1946 mg/ml equivalent to melphalan 10 mg excipient: hydrochloric acid povidone water for injection ethanol propylene glycol sodium citrate dihydrate water for injection - melphalan injection, administered by regional arterial perfusion, is indicated in the treatment of: - localised malignant melanoma of the extremities; - localised soft tissue sarcoma of the extremities.

Europska Unija - engleski - EMA (European Medicines Agency)

adienne s.r.l. s.u. - melphalan hydrochloride - multiple myeloma; hodgkin disease; lymphoma, non-hodgkin; precursor cell lymphoblastic leukemia-lymphoma; leukemia, myeloid, acute; neuroblastoma; ovarian neoplasms; hematopoietic stem cell transplantation - antineoplastic agents - high-dose of phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (hodgkin, non-hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma.phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (ric) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-hsct) in malignant haematological diseases in adults.phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:myeloablative conditioning (mac) treatment in case of malignant haematological diseasesric treatment in case of non-malignant haematological diseases.

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

emcure pharmaceuticals pty ltd - melphalan hydrochloride, quantity: 55.97 mg (equivalent: melphalan, qty 50 mg) - injection, diluent for - excipient ingredients: sodium citrate dihydrate; ethanol; water for injections; propylene glycol - for?the?treatment?of?patients?with?multiple?myeloma?for?whom?oral therapy?is?not?appropriate

Izrael - engleski - Ministry of Health

padagis israel agencies ltd, israel - melphalan - tablets - melphalan 2 mg - melphalan - melphalan - for the treatment of : multiple myeloma and advanced ovarian adenocarcinoma