Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
LENALIDOMIDE
NEOPHARM SCIENTIFIC LTD
L04AX04
HARD CAPSULE
LENALIDOMIDE 25 MG
PER OS
Required
CELGENE EUROPE LTD, UK
LENALIDOMIDE
Multiple Myeloma (MM)Revlimid is indicated for the treatment of multiple myeloma.Myelodysplastic Syndromes REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.Revlimid 7.5 mg is not indicated for treatment in MDS.Mantle Cell LymphomaREVLIMID is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma.
2014-04-30
9 201 / 9 0 דבכנ ת/חקור ,ה/אפור / ה , לע ךעידוהל החמש םרפואינ לש הרושיא היוותה תפסות רישכתל :םי REVLIMID 2.5 MG Hard Capsule דימילבר 2.5 ג"מ החישק היילבט REVLIMID 5 MG Hard Capsule דימילבר 5 ג"מ החישק היילבט REVLIMID 7.5 MG Hard Capsule דימילבר 7.5 ג"מ החישק היילבט REVLIMID 10 MG Hard Capsule דימילבר 10 ג"מ החישק היילבט REVLIMID 15 MG Hard Capsule דימילבר 15 ג"מ החישק היילבט REVLIMID 20 MG Hard Capsule דימילבר 20 ג"מ החישק היילבט REVLIMID 25 MG Hard Capsule דימילבר 25 ג"מ החישק היילבט םירמוחה םיליעפה :םתומכו Revlimid 2.5 mg: each hard capsule contains 2.5 mg Lenalidomide. Revlimid 5 mg: each hard capsule contains 5 mg Lenalidomide. Revlimid 7.5 mg: each hard capsule contains 7.5 mg Lenalidomide. Revlimid 10 mg: each hard capsule contains 10 mg Lenalidomide. Revlimid 15 mg: each hard capsule contains 15 mg Lenalidomide. Revlimid 20 mg: each hard capsule contains 20 mg Lenalidomide. Revlimid 25 mg: each hard capsule contains 25 mg Lenalidomide. :השדחה היוותהה חסונ MULTIPLE MYELOMA Revlimid is indicated for: •The maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. • Previously untreated multiple myeloma in adult patients who are not eligible for transplant. • In combination with dexamethasone treatment of multiple myeloma patients who have received at least one prior therapy. MYELODYSPLASTIC SYNDROMES REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate- 1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid 7.5 mg is not indicated for treatment in MDS. MANTLE CELL LYMPHOMA REVLIMID is indicated for the treatment of adult patients with relapsed and Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODUCT Revlimid 2.5 mg, hard capsules Revlimid 5 mg, hard capsules Revlimid 7.5 mg, hard capsules Revlimid 10 mg, hard capsules Revlimid 15 mg, hard capsules Revlimid 20 mg, hard capsules Revlimid 25 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revlimid 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 73.5 mg of lactose (as anhydrous lactose). Revlimid 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 147 mg of lactose (as anhydrous lactose). Revlimid 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 144.5 mg of lactose (as anhydrous lactose). Revlimid 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 294 mg of lactose (as anhydrous lactose). Revlimid 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 289 mg of lactose (as anhydrous lactose). Revlimid 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 244.5 mg of lactose (as anhydrous lactose). Revlimid 25 mg hard capsules Each capsule contains 25 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 200 mg of lactose (as anhydrous lactose). 2 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Revlimid 2.5 mg hard capsules Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”. Revlimid 5 mg hard capsules White capsules, size 2, 18.0 mm, marked “REV 5 mg”. Revlimid 7.5 mg hard capsules Pale yellow/white capsules, size 2, 18.0 mm, marked “REV 7.5 mg”. Revlimid 10 mg hard capsules Blue-green/pale yellow capsules, size 0, 21.7 mm, marked “REV 10 mg”. Revlimid 15 mg hard capsules Pale blue/white capsules, size 0, 21.7 mm, marked “REV 15 mg Baca dokumen lengkap