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Corola-website/Law/228086_a_229415

No If the answer to 1.2 is yes, continue with section 2A and omit section 2B. If the answer to 1.2 is no, omit section 2A and continue with section 2B. 2.A.1. Marketing Authorisation number: Date of Marketing Authorisation: 2.A.2. Product licence holder (name and address): Name: Address: 2.A.3. Status of product licence holder: a b c 2.A.3.1. For categories b and c the name and address of the manufacturer

ORDIN nr. 1.447 din 24 noiembrie 2010 privind modificarea anexei la Ordinul ministrului sănătăţii publice nr. 894/2006 pentru aprobarea Reglementărilor privind exportul medicamentelor de uz uman. In: EUR-Lex (2010) [Corola-website/Law/228086_a_229415]
the answer to 1.2 is no, omit section 2A and continue with section 2B. 2.A.1. Marketing Authorisation number: Date of Marketing Authorisation: 2.A.2. Product licence holder (name and address): Name: Address: 2.A.3. Status of product licence holder: a b c 2.A.3.1. For categories b and c the name and address of the manufacturer producing the dosage form is: 2.A.4. Is a summary basis for approval appended? Yes No 2

ORDIN nr. 1.447 din 24 noiembrie 2010 privind modificarea anexei la Ordinul ministrului sănătăţii publice nr. 894/2006 pentru aprobarea Reglementărilor privind exportul medicamentelor de uz uman. In: EUR-Lex (2010) [Corola-website/Law/228086_a_229415]
for the accuracy of the translation of the text from Romanian into English. 2.A.6. Applicant for certificate, if different from licence holder (name and address): 2.B.1. Applicant for certificate (name and address): 2.B.2. Status of applicant: a b c 2.B.2.1. For categories (b) and (c) the name and address of the manufacturer producing the dosage form is: 2.B.3. Why is marketing authorization lacking? Not Required Not Requested Under Consideration Refused

ORDIN nr. 1.447 din 24 noiembrie 2010 privind modificarea anexei la Ordinul ministrului sănătăţii publice nr. 894/2006 pentru aprobarea Reglementărilor privind exportul medicamentelor de uz uman. In: EUR-Lex (2010) [Corola-website/Law/228086_a_229415]
Corola-website/Law/228063_a_229392

Rituximabul utilizat la pacienții cu vasculită crioglobulinemică cu hepatită C asociată ar putea fi de asemenea util în vasculitele esențiale crioglobuline mice non-viral asociate. (71) 1. C Mukhtyar, L Guillevin, M C Cid, et al.: EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis 2009; 68: 318-323. 2. Lenton J, Donnelly R, Nash JR. Does temporal artery biopsy influence the management of temporal arteritis? QJM 2006;99:33-6. Gonzalez-Gay MA, Blanco R, Rodriguez-Valverde V, Martinez-Taboada VM, 3. Delgado-Rodriguez

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Arthritis Rheum 1998;41:1497-504. 4. Kerr GS, Hallahan CW, Giordano J, et al: Takayasu arteritis. Ann Intern Med 120:919,1994) 5. Maksimowicz-McKinnon K, Clark TM, Hoffman GS. Limitations of therapy and a guarded prognosis în an American cohort of Takayasu arteritis patients. Arthritis Rheum 2007;56:1000-9. 6. Park MC, Lee SW, Park YB, Chung NS, Lee SK. Clinical characteristics and outcomes of Takayasu's arteritis: analysis of 108 patients using standardized criteria for diagnosis, activity assessment, and angiographic

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
arteritis using induction therapy with highdose glucocorticoids: a double-blind, placebo-controlled, randomized prospective clinical trial. Arthritis Rheum 2006;54:3310-8. 8. Hoffman GS, Cid MC, Hellmann DB, Guillevin L, Stone JH, Schousboe J, et al. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum 2002;46:1309-18. 9. Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, et al. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
J, et al. A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum 2002;46:1309-18. 9. Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, et al. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med 2007;146:621-30. 10. Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, FernandezGutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. A randomized, double-blind

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
A multicenter, randomized, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis. Arthritis Rheum 2002;46:1309-18. 9. Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, et al. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med 2007;146:621-30. 10. Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, FernandezGutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. A randomized, double-blind, placebo-controlled trial. Ann

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Weyand CM, Stone JH, et al. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med 2007;146:621-30. 10. Jover JA, Hernandez-Garcia C, Morado IC, Vargas E, Banares A, FernandezGutierrez B. Combined treatment of giant-cell arteritis with methotrexate and prednisone. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 2001;134:106-14. 11. Hunder GG, Sheps SG, Allen GL, Joyce JW. Daily and alternate-day corticosteroid regimens în treatment of giant cell arteritis: comparison în a

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
11. Hunder GG, Sheps SG, Allen GL, Joyce JW. Daily and alternate-day corticosteroid regimens în treatment of giant cell arteritis: comparison în a prospective study. Ann Intern Med 1975;82:613-8. 12. Danesh-Meyer H, Savino PJ, Gamble GG. Poor prognosis of visual outcome after visual loss from giant cell arteritis. Ophthalmology 2005;112:1098-103. 13. Hayreh SS, Zimmerman B, Kardon RH. Visual improvement with corticosteroid therapy în giant cell arteritis. Report of a large study and review of literature. Acta Ophthalmol

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
12. Danesh-Meyer H, Savino PJ, Gamble GG. Poor prognosis of visual outcome after visual loss from giant cell arteritis. Ophthalmology 2005;112:1098-103. 13. Hayreh SS, Zimmerman B, Kardon RH. Visual improvement with corticosteroid therapy în giant cell arteritis. Report of a large study and review of literature. Acta Ophthalmol Scand 2002;80:355-67. 14. Chan CC, Paine M, O'Day J. Steroid management în giant cell arteritis. Br J Ophthalmol 2001;85:1061-4. 15. Foroozan R, Deramo VA, Buono LM

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
therapy în preventing glucocorticoid-induced bone loss în patients with inflammatory rheumatic diseases. A randomized study. Rev Rhum Engl Ed 1999;66:214-9. 20. Tso E, Flamm SD, White RD, Schvartzman PR, Mascha E, Hoffman GS. Takayasu arteritis: utility and limitations of magnetic resonance imaging în diagnosis and treatment. Arthritis Rheum 2002;46:1634-42. 21. Choe YH, Han BK, Koh EM, Kim DK, Do YS, Lee WR. Takayasu's arteritis: assessment of disease activity with contrast-enhanced MR imaging. AJR Am J Roentgenol

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
PR, Mascha E, Hoffman GS. Takayasu arteritis: utility and limitations of magnetic resonance imaging în diagnosis and treatment. Arthritis Rheum 2002;46:1634-42. 21. Choe YH, Han BK, Koh EM, Kim DK, Do YS, Lee WR. Takayasu's arteritis: assessment of disease activity with contrast-enhanced MR imaging. AJR Am J Roentgenol 2000;175:505-11. 22. Webb M, Chambers A, A AL-N, Mason JC, Maudlin L, Rahman L, et al. The role of 18F-FDG PET în characterising disease activity în Takayasu

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Shelhamer JH, Volkman DJ, Parrillo JE, Lawley TJ, Johnston MR, Fauci AS. Takayasu's arteritis and its therapy. Ann Intern Med 1985;103:121-6. 30. Daina, E, Schieppati, A, Remuzzi, G. Mycophenolate mofetil for the treatment of Takayasu arteritis: report of three cases. Ann Intern Med 1999; 130:422. 31. Haberhauer, G, Kittl, EM, Dunky, A, et al. Beneficial effects of leflunomide în glucocorticoid- and methotrexate-resistant Takayasu's arteritis. Clin Exp Rheumatol 2001; 19:477 32. Hoffman, GS, Merkel, PA, Brasington

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Med 1985;103:121-6. 30. Daina, E, Schieppati, A, Remuzzi, G. Mycophenolate mofetil for the treatment of Takayasu arteritis: report of three cases. Ann Intern Med 1999; 130:422. 31. Haberhauer, G, Kittl, EM, Dunky, A, et al. Beneficial effects of leflunomide în glucocorticoid- and methotrexate-resistant Takayasu's arteritis. Clin Exp Rheumatol 2001; 19:477 32. Hoffman, GS, Merkel, PA, Brasington, RD, et al. Anti-tumor necrosis factor therapy în patients with difficult to treat Takayasu arteritis. Arthritis Rheum 2004; 50:22960

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Lee MS, Smith SD, Galor A, Hoffman GS. Antiplatelet and anticoagulant therapy în patients with giant cell arteritis. Arthritis Rheum 2006;54:3306-9. 34. Nesher G, Berkun Y, Mates M, Baras M, Rubinow A, Sonnenblick M. Lowdose aspirin and prevention of cranial ischemic complications în giant cell arteritis. Arthritis Rheum 2004;50:1332-7. 35. C Mukhtyar, L Guillevin, M C Cid, et al.: EULAR recommendations for the managementof primary small and medium vessel vasculitis. Ann Rheum Dis 2009 68: 310-317 36

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Wegener's granulomatosis etanercept trial. Arthritis Rheum 2003;48:2299-309. 40. Guillevin L, Jarrousse B, Lok C, Lhote F, Jais JP, Le Thi Huong Du D, et al. Longterm followup after treatment of polyarteritis nodosa and Churg-Strauss angiitis with comparison of steroids, plasma exchange and cyclophosphamide to steroids and plasma exchange. A prospective randomized trial of 71 patients. The Cooperative Study Group for Polyarteritis Nodosa. J Rheumatol 1991;18:567-74. 41. Koldingsnes W, Nossent JC. Baseline features and initial treatment as

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Nossent JC. Baseline features and initial treatment as predictors of remission and relapse în Wegener's granulomatosis. J Rheumatol 2003;30:80-8. 42. Jayne D, Rasmussen N, Andrassy K, Bacon P, Tervaert JW, Dadoniene J, et al. A randomized trial of maintenance therapy for vasculitis associated with antineutrophil cytoplasmic autoantibodies. N Engl J Med 2003;349:36-44. 43. Aasarod K, Bostad L, Hammerstrom J, Jorstad S, Iversen BM. Renal histopathology and clinical course în 94 patients with Wegener's granulomatosis. Nephrol

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
J, Jorstad S, Iversen BM. Renal histopathology and clinical course în 94 patients with Wegener's granulomatosis. Nephrol Dial Transplant 2001;16:953-60. 44. Adu D, Pall A, Luqmani RA, Richards NT, Howie AJ, Emery P, et al. Controlled trial of pulse versus continuous prednisolone and cyclophosphamide în the treatment of systemic vasculitis. QJM 1997;90:401-9. 45. Rihova Z, Jancova E, Merta M, Zabka J, Rysava R, Bartunkova J, et al. Daily oral versus pulse intravenous cyclophosphamide în the therapy

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Holl-Ulrich K, Gross WL. Urinary bladder cancer în Wegener's granulomatosis: is it more than cyclophosphamide? Ann Rheum Dis 2004;63:1183-5. 49. De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, et al. Randomized trial of cyclophosphamide versus methotrexate for induction of remission în early systemic antineutrophil cytoplasmic antibodyassociated vasculitis. Arthritis Rheum 2005;52:2461-9. 50. Hoffman GS, Leavitt RY, Kerr GS, Fauci AS. The treatment of Wegener's granulomatosis with glucocorticoids and methotrexate. Arthritis Rheum

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
cancer în Wegener's granulomatosis: is it more than cyclophosphamide? Ann Rheum Dis 2004;63:1183-5. 49. De Groot K, Rasmussen N, Bacon PA, Tervaert JW, Feighery C, Gregorini G, et al. Randomized trial of cyclophosphamide versus methotrexate for induction of remission în early systemic antineutrophil cytoplasmic antibodyassociated vasculitis. Arthritis Rheum 2005;52:2461-9. 50. Hoffman GS, Leavitt RY, Kerr GS, Fauci AS. The treatment of Wegener's granulomatosis with glucocorticoids and methotrexate. Arthritis Rheum 1992;35:1322-9. 51. Sneller MC

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
2461-9. 50. Hoffman GS, Leavitt RY, Kerr GS, Fauci AS. The treatment of Wegener's granulomatosis with glucocorticoids and methotrexate. Arthritis Rheum 1992;35:1322-9. 51. Sneller MC, Hoffman GS, Talar-Williams C, Kerr GS, Hallahan CW, Fauci AS. An analysis of forty-two Wegener's granulomatosis patients treated with methotrexate and prednisone. Arthritis Rheum 1995;38:608-13. 52. Stone JH, Tun W, Hellman DB. Treatment of non-life threatening Wegener's granulomatosis with methotrexate and daily prednisone as the initial therapy of choice

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
Muhler M, Reinhold-Keller E, Paulsen J, Gross WL. Induction of remission în Wegener's granulomatosis with low dose methotrexate. J Rheumatol 1998;25:492-5. 56. Metzler C, Hellmich B, Gause A, Gross WL, de Groot K. Churg-Strauss syndrome - successful induction of remission with methotrexate and unexpected high cardiac and pulmonary relapse ratio during maintenance treatment. Clin Exp Rheumatol 2004;22(Suppl 36):S52-61. 57. Chakravarty K, McDonald H, Pullar T, Taggart A, Chalmers R, Oliver S, et al. BSR/BHPR guideline

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
maintenance treatment. Clin Exp Rheumatol 2004;22(Suppl 36):S52-61. 57. Chakravarty K, McDonald H, Pullar T, Taggart A, Chalmers R, Oliver S, et al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy în consultation with the British Association of Dermatologists. Rheumatology (Oxford) 2008;47:924-5. 58. Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, et al. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]
al. BSR/BHPR guideline for disease-modifying anti-rheumatic drug (DMARD) therapy în consultation with the British Association of Dermatologists. Rheumatology (Oxford) 2008;47:924-5. 58. Jayne DR, Gaskin G, Rasmussen N, Abramowicz D, Ferrario F, Guillevin L, et al. Randomized trial of plasma exchange or high-dosage methylprednisolone as adjunctive therapy for severe renal vasculitis. J Am Soc Nephrol 2007;18:2180-8. 59. Allen A, Pusey C, Gaskin G. Outcome of renal replacement therapy în antineutrophil cytoplasmic antibody-associated systemic vasculitis. J Am Soc

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea reumatologie*) - "GHID DE TRATAMENT AL VASCULITELOR PRIMARE SISTEMICE" - Anexa 4. In: EUR-Lex (2010) [Corola-website/Law/228063_a_229392]