New designations August 2011
Treatment of multiple myelomaAcadesine
Treatment of focal segmental glomerulosclerosisFresolimumab
Treatment for mobilisation of progenitor cells prior to stem cell transplantationLow molecular weight dextran sulfate
Prevention of ischaemia/reperfusion injury associated with solid organ transplantationMethyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]- N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-α-asparaginyl-4-aminobutanoyl-N6-[5-[(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno[3,4-d]imidazol-4-yl]-1-oxopentyl]-Llysyl] amino]ethoxy]ethoxy]ethoxy]ethyl]-2,3-di-O-methyl-6-O-sulfo-α-Dglucopyranosyl-(1->4)- O-2,3-di-O-methyl-β-D-glucopyranuronosyl-(1->4)- O-2,3,6-tri-
O-sulfo-α-D-glucopyranosyl-(1->4)- O-2,3-di-O-methyl-α-L-idopyranuronosyl-(1->4)-3-
O-methyl-α-D-glucopyranoside 2,6-bis(hydrogen sulfate) octasodium salt
Treatment of pancreatic cancerMixture of seven synthetic fragments consisting of p21 RAS peptides
Treatment of post-polycythaemia vera myelofibrosisN-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Treatment of post-essential thrombocythaemia myelofibrosisN-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Treatment of primary myelofibrosisN-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt
Treatment of acute lymphoblastic leukaemiaPegylated recombinant Erwinia chrysanthemi L-asparaginase
Treatment of hepatocellular carcinomaPeretinoin
Post-exposure prophylaxis of inhalation anthrax diseaseHuman anthrax monoclonal antibody
Treatment of 5q spinal muscular atrophy5-[1-(2,6-dichlorobenzyl)piperidin-4-ylmethoxy]quinazoline-2,4-diamine dihydrochloride
Treatment of acute liver failureCardiotrophin-1
Treatment of gastric cancerEverolimus
Treatment of Niemann-Pick disease, type CHydroxy-propyl-beta-cyclodextrin
Treatment of cystic fibrosisMultilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phospatidylinositol and cholesterol
Treatment of tuberculosisN-{[(5S)-3-(3-fluoro-4-thiomorpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl}acetamide
Treatment of chronic non-infectious uveitisSirolimus
New Marketing Authorisations
Tobi Podhaler
[tobramycin]Novartis Europharm Limited
United Kingdom
What is Tobi Podhaler?
Tobi Podhaler is a medicine that contains the active substance tobramycin. It is available as capsules (28 mg) containing a dry powder for inhalation using a portable inhaler device.
What is Tobi Podhaler used for?
Tobi Podhaler is used to suppress chronic lung infection caused by bacteria called Pseudomonas aeruginosa in adults and children aged six years and over who have cystic fibrosis. Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas which secrete fluids such as mucus and digestive juices. The accumulation of mucus in the lungs allows bacteria to grow more easily causing infections, lung damage and breathing problems. Bacterial lung infection with P. aeruginosa is frequent in cystic fibrosis patients.
Because the number of patients with cystic fibrosis and P. aeruginosa bacterial lung infection is low, the disease is considered 'rare' and Tobi Podhaler was designated an 'orphan medicine' (a medicine used in rare diseases) on 17 March 2003.
The medicine can only be obtained with a prescription.
All Orphan Drugs in Europe
European Public Assessment Reports (EPARs) >>
open here please to see/read/learn about Orphan Drugs:
Register of designated Orphan Medicinal Products (alphabetical)
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