Melpha Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

melpha

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.

Alkeran Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

alkeran

pharmacy retailing (nz) ltd t/a healthcare logistics - melphalan 2mg - film coated tablet - 2 mg - active: melphalan 2mg excipient: colloidal silicon dioxide crospovidone magnesium stearate microcrystalline cellulose opadry white ys-1-18097-a

ALKERAN TABLET 2 mg (Revised formula) Singapura - Inggris - HSA (Health Sciences Authority)

alkeran tablet 2 mg (revised formula)

dch auriga singapore - melphalan - tablet, film coated - 2.00 mg - melphalan 2.00 mg

HIGHLIGHTS OF PRESCRIBING INFORMATION Amerika Serikat - Inggris - NLM (National Library of Medicine)

highlights of prescribing information

oncopeptides, ab - melphalan flufenamide hydrochloride (unii: 3412470a0v) (melphalan flufenamide - unii:f70c5k4786) - pepaxto is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one cd38-directed monoclonal antibody. this indication is approved under accelerated approval based on response rate. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s) [see clinical studies (14)] . limitations of use pepaxto is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials [see warnings and precautions (5.5)]. pepaxto is contraindicated in patients with a history of serious hypersensitivity reaction to melphalan flufenamide or melphalan [see adverse reactions (6.1)] . risk summary based on its mechanism of action [see clinical pharmacology (12.1)] , pepaxto ca