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Corola-website/Law/228086_a_229415

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.A.5. Is the attached, officially approved product information complete and consonent with the licence? Yes Not Provided The applicant assumes the whole responsibility for the accuracy of the translation of the text from Romanian

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]
dosage form is: 2.A.4. Is a summary basis for approval appended? Yes No 2.A.5. Is the attached, officially approved product information complete and consonent with the licence? Yes Not Provided The applicant assumes the whole responsibility 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

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]
5. Is the attached, officially approved product information complete and consonent with the licence? Yes Not Provided The applicant assumes the whole responsibility 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

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]
Yes Not Provided The applicant assumes the whole responsibility 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

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]
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 2.B.4. Remarks: 3. Does the certifying authority

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]
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 2.B.4. Remarks: 3. Does the certifying authority arrange for periodic inspecțion of the manufacturing plant în which the dosage form is produced: Yes No Not Applicable 3.1. Periodicity of routine inspecțions (years): 3.2. Hâș the manufacture of this type of dosage form been inspected? Yes No 3

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

recomandare D) (35). 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

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]
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 classification. Scand J Rheumatol 2005;34:284-92. 7. Mazlumzadeh M, Hunder GG, Easley KA, Calamia KT, Matteson EL, Griffing WL, et al. Treatment of giant cell arteritis using induction therapy with highdose glucocorticoids: a 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]
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. Ann Intern Med 2007

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]
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. 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

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]
Poutanen VP, Pajari RI, et al. Ultrasonography în the quantification of arterial involvement în Takayasu's arteritis. Scand J Rheumatol 2000;29:56-61. 26. Mahr AD, Jover JA, Spiera RF, Hernandez-Garcia C, Fernandez-Gutierrez B, Lavalley MP, et al. Adjunctive methotrexate for treatment of giant cell arteritis: an individual patient data meta-analysis. Arthritis Rheum 2007;56:2789-97. 27. Valsakumar AK, Valappil UC, Jorapur V, Garg N, Nityanand S, Sinha N. Role of immunosuppressive therapy on clinical, immunological, and angiographic outcome în active

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]
methotrexate. Arthritis Rheum 1994;37:578-82. 29. 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

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]
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. (Seo P, Stone JH. The antineutrophil cytoplasmic antibody-associated vasculitides. Am J Med. 2004;117(1):39-50.) 37. (Cotch MF, Hoffman GS, Yerg DE, Kaufman GI

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]
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 predictors of remission and relapse în Wegener's granulomatosis. J Rheumatol 2003;30:80-8. 42. Jayne D, Rasmussen N, Andrassy K, Bacon

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]
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 Dial Transplant 2001

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]
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 1992;35:1322-9. 51

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]
C, Sneller MC. Use of methotrexate and glucocorticoids în the treatment of Wegener's granulomatosis. Long-term renal outcome în patients with glomerulonephritis. Arthritis Rheum 2000;43:1836-40. 54. Wegener's Granulomatosis Etanercept Trial (WGET) Research Group Etanercept plus standard therapy for Wegener's granulomatosis. N Engl J Med 2005;352:351-61. 55. de Groot K, 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

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]
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 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

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 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 Nephrol 1998;9:1258-63. 60. Guillevin L, Fain O

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]
Positive classic antineutrophil cytoplasmic antibody (C-ANCA) titer at switch to azathioprine therapy associated with relapse în proteinase 3-related vasculitis. Arthritis Rheum 2004;51:269-73. 62. Langford CA, Talar-Williams C, Barron KS, Sneller MC. Use of a cyclophosphamideinduction methotrexate-maintenance regimen for the treatment of Wegener's granulomatosis: extended follow-up and rate of relapse. Am J Med 2003;114:463-9. 63. Reinhold-Keller E, Fink CO, Herlyn K, Gross WL, De Groot K. High rate of renal relapse în 71 patients with Wegener

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]
with Wegener's granulomatosis under maintenance of remission with low-dose methotrexate. Arthritis Rheum 2002;47:326-32. 64. Metzler C, Miehle N, Manger K, Iking-Konert C, de Groot K, Hellmich B, et al. Elevated relapse rate under oral methotrexate versus leflunomide for maintenance of remission în Wegener's granulomatosis. Rheumatology (Oxford) 2007;46:1087-91. 65. Boomsma MM, Stegeman CA, van der Leij MJ, Oost W, Hermans J, Kallenberg CG, et al. Prediction of relapses în Wegener's granulomatosis by measurement of antineutrophil

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]
Kallenberg CG, et al. Prediction of relapses în Wegener's granulomatosis by measurement of antineutrophil cytoplasmic antibody levels: a prospective study. Arthritis Rheum 2000;43:2025-33. 66. Birck R, Schmitt WH, Kaelsch IA, van der Woude FJ. Serial ANCA determinations for monitoring disease activity în patients with ANCAassociated vasculitis: a systematic review. Am J Kidney Dis 2006;47:15-23. 67. Finkielman JD, Merkel PA, Schroeder D, Hoffman GS, Spiera R, St Clair EW, et al. Antiproteinase 3 antineutrophil cytoplasmic antibodies and

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]
and disease activity în Wegener granulomatosis. Ann Intern Med 2007;147:611-9 68. Koukoulaki M, Jayne DR. Mycophenolate mofetil în anti-neutrophil cytoplasm antibodies-associated systemic vasculitis. Nephron Clin Pract 2006;102:c100-7. 69. Langford CA, Talar-Williams C, Sneller MC. Mycophenolate mofetil for remission maintenance în the treatment of Wegener's granulomatosis. Arthritis Rheum 2004;51:278-83. 70. Nowack R, Gobel U, Klooker P, Hergesell O, Andrassy K, van der Woude FJ. Mycophenolate mofetil for maintenance therapy of Wegener's granulomatosis andmicroscopic polyangiitis

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]
Langford CA, Talar-Williams C, Sneller MC. Mycophenolate mofetil for remission maintenance în the treatment of Wegener's granulomatosis. Arthritis Rheum 2004;51:278-83. 70. Nowack R, Gobel U, Klooker P, Hergesell O, Andrassy K, van der Woude FJ. Mycophenolate mofetil for maintenance therapy of Wegener's granulomatosis andmicroscopic polyangiitis: a pilot study în 11 patients with renal involvement. J Am Soc Nephrol 1999;10:1965-71. 71. Zaja F, De Vita S, Mazzaro C, Sacco S, Damiani D, De Marchi G, et

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]
Corola-website/Law/229223_a_230552

de PC care să permită legătura constantă dintre centrele de endocrinologie - medicii endocrinologi din teritoriu și pacienți pentru asigurarea unei monitorizări corecte Acest proiect este realizat prin adaptarea pentru România a ghidului Societății Europene de Endocrinologie: Consensus Statement: European Consensus for the Management of Patients with Differential Thyroid Carcinoma of the Follicular Epithelium. European Journal of Endocrinology, 2006, 154: 787-803 --------

GHID din 18 octombrie 2010 de practică medicală pentru specialitatea endocrinologie*) - "GHID PENTRU DIAGNOSTICUL ŞI TRATAMENTUL CANCERULUI TIROIDIAN DIFERENŢIAT DERIVAT DIN EPITELIUL FOLICULAR" - Anexa 5. In: EUR-Lex (2010) [Corola-website/Law/229223_a_230552]