Ορφανά φάρμακα (FDA) που εισάγονται μέσω ΙΦΕΤ
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Ορφανά φάρμακα (FDA) που εισάγονται μέσω ΙΦΕΤ |
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Ταξινόμηση κατά δραστική ουσία | |||
| Επιλέξτε εδώ για να πάρετε αρχείο excel | PRODUCT | ACTIVE INGREDIENT | Orphan Designation: | SPONSOR | ΔΙΑΘΕΣΗ |
| ADAGEN | Pegademase Bovine | Enzon, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ | |
| ALKERAN For Injection | Melphalan | For the palliative treatment of patients with multiple myeloma for whom oral melphalan is not appropriate. | Glaxo Wellcome Inc. | STOCK |
| AMMONUL | Benzoate/Phenylacetate | Adjunctive therapy in the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. | Medicis Pharmaceutical Corp. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| CAFCIT | Caffeine | Short term treatment of apnea of prematurity in infants between 28 and less than 33 weeks gestational age. | O.P.R. Development, L.P. | STOCK |
| CYANOCIT | Hydroxocobalamin | Treatment on known or suspected cyanide poisoning | Merck Sante, s.a.a. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| CYSTADANE | Betaine | Treatment of homocystinuria to decrease elevated homocysteine blood levels. | Jazz Pharmaceuticals | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| CYSTAGON | Cysteamine | Treatment of nephropathic cystinosis in adults and children. | Mylan Laboratories, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| DACOGEN | Decitabine | for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups | Eisai, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| DEPOCYT | Cytarabine Liposomal | Intrathecal treatment of lymphomatous meningitis. | Pacira Pharmaceuticals, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| DIGIBIND | Digoxin Immune Fab (Ovine) | Glaxo Wellcome Inc. | STOCK | |
| ELMIRON | Pentosan Polysulfate Sodium | Relief of bladder pain or discomfort associated with interstitial cystitis. | Alza Corporation | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| FLOLAN | Epoprostenol | Long-term intravenous treatment of primary pulmonary hypertension in NYHA Class III and Class IV patients. | Glaxo Wellcome Inc. | STOCK |
| FLOLAN | Epoprostenol | For the long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in New York Heart Association (NYHA) Class III and Class IV patients who do not respond adequately to conventional therapy. | GlaxoSmithKline LLC | STOCK |
| FOLOTYN | Pralatrexate | Treatment of patients with relapsed or refractory peripheral T-cell lymphoma | Allos Therapeutics, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| GALZIN | Zinc Acetate | For maintenance treatment of patients with Wilson's disease who have been initially treated with a chelating agent. | Lemmon Company | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| LEUKINE | Sargramostim | Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. | Immunex Corporation | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| LIDODERM Patch | Lidocaine Patch 5% | Teikoku Pharma USA, Inc. | STOCK ΩΣ VERSATIS | |
| LIORESAL Intrathecal | Baclofen | Management of severe spasticity of spinal cord origin in patients who are unresponsive to oral baclofen therapy or experience intolerable CNS side effects at effective doses. | Medtronic, Inc. | STOCK |
| MYCOBUTIN | Rifabutin | Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infections. | Adria Laboratories, Inc. | STOCK |
| MYLOTARG | Gemtuzumab Zogamicin | Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy | Wyeth-Ayerst Laboratories | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| n/a | Desmopressin Acetate | Treatment of patients with hemophilia A or von Willebrand's disease (type I) whose factor VIII coagulant activity level is greater than 5%. | Aventis Behring L.L.C. | STOCK ΩΣ DDAVP |
| NAGLAZYME | N-Acetylgalactosamine-4-Sulfatase, Recombinant Human | For patients with mucopolysaccharidosis VI. Galsulfase has been shown to improve walking and stair-climbing capacity. | BioMarin Pharmaceutical, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| ONCASPAR | Pegaspargase | Combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of L-asparaginase. | Enzon, Inc. | STOCK |
| ONTAK | Denileukin Diftitox | Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. | Eisai, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| ORFADIN | Nitisinone | Adjunctive therapy to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 | Rare Disease Therapeutics, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| PASER Granules | Aminosalicylic Acid | Treatment of tuberculosis | Jacobus Pharmaceutical Company | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| PROLASTIN | Alpha1-Proteinase Inhibitor (Human) | For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema. | Bayer Corporation | STOCK |
| RIASTAP | Human Fibrinogen Concentrate, Pasteurized | Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia | CSL Behring, LLC | STOCK |
| RIFADIN I.V. | Rifampin | Hoechst Marion Roussel | STOCK | |
| SOLIRIS | Eculizumab | Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis | Alexion Pharmaceuticals, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |
| SULFAMYLON Solution | Mafenide Acetate Solution | Mylan Laboratories, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ | |
| SYPRINE | Trientine Hcl | Merck Sharp & Dohme Research | STOCK ΩΣ TRIENTINE | |
| THIOLA | Tiopronin | Pak, Charles Y.C. M.D. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ | |
| TREANDA | Bendamustine Hydrochloride | Treatment of patients with chronic lymphocytic leukemia | Cephalon, Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ ΩΣ RIBOMUSTINE |
| VUMON For Injection | Teniposide | Induction therapy in patients with refractory childhood acute lymphoblastic leukemia when used in combination with other approved anticancer agents. | Bristol-Myers Squibb Pharmaceutical Research Institute | STOCK |
| XENAZINE | Tetrabenazine | Treatment of chorea associated with Huntington's disease | Prestwick Pharmaceuticals, Inc | STOCK |
| ZOLINZA | Vorinostat | Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistant or recurrent disease on or following two systemic therapies. | Merck & Co., Inc. | ΕΙΔΙΚΗ ΠΑΡΑΓΓΕΛΙΑ |