Methylprednisolone

· Metacam · Meloxicam · Part B extension

EMEA/MB/050/00 Relatório Anual 2000 Page 79/88 Medicamento Empresa Área terapêutica Apresentação EMEA/CVMP Comissão -Denom. -Nome -Espécie -Forma -Validação -Parecer recebido comercial em -DCI -Origem -Indicação -Dosagem -Parecer -Data da decisão -Parte A/B -Número de -Tempo activo -Notificação apresentações -Tempo inactivo -Jornal Oficial Econor Novartis Pigs 10%/50% premix -12. 10. 1999 -07. 04. 2000 Valnemulin A Prevention various -08. 03. 2000 -15. 09. 2000 Parte B/treatment of 2 -148 days -22. 09. 2000 (extension) dysentery and -0 -OJ C 308, treatment/control of 27. 10. 2000 enzootic pneumonia (QJ01XX94) Dicural Fort Cattle pigs Solution for injection -16. 12. 1998 -21. 07. 2000 Difloxacin Dodge Antibacterial for 50 mg/ml -21. 06. 2000 -24. 10. 2000 Parte B Animal systemic use 3 -203 days -25. 10. 2000 (extension) Health (QJ01MA) -351 days -OJ C 337, NL 28. 11. 2000 Poulflox Virbac Poultry Oral solution -09. 12. 1999 -21. 07. 2000 Difloxacin S. A.Antibacterial for 100 mg/ml -21. 06. 2000 -16. 11. 2000 Parte B F systemic use 3 -152 days -OJ C 2, QJ01MA94) -43 days 05. 01. 2001 Bayovac CSF Bayer Pigs Emulsion for injection -16. 12. 1998 -07. 08. 2000 Marker D Marker vaccine E2 glycoprotein of -19. 07. 2000 Live vaccine against Classical Classical Swine Fever -210 days Parte A Swine Fever virus -309 days (QJ57EA) 4 Porcilis AR-T -Intervet Pigs Suspension for injection -12. 01. 1999 -18. 08. 2000 DF Internati Vaccine against 2 ml -19. 07. 2000 -16. 11. 2000 Inactivated onal atrophic rhinitis 2 -204 days -OJ C 2, vaccine NL (QJ57EA) -336 days 05. 01. 2001 Parte A Pruban Intervet Dogs Cream -15. 09. 1998 -18. 08. 2000 Rescortol Internati Anti-inflammatory 1 mg/g -19. 07. 2000 -16. 11. 2000 butyrate onal for cutaneous 1 -196 days -OJ C 2, Parte B NL inflammatory -477 days 05. 01. 2001 disorders (QD07AC90) Pirsue Pharmaci Dairy cattle Sterile solution for -12. 01. 1999 -10. 11. 2000 Pirlimycin a Clinical sub -intramammary use -11. 10. 2000 Parte B UpOJhn clinical mastitis 5 mg/ml -210 days B (QJ51FF90) 4 -428 days Zubrin Schering Dogs Oral lyophilisate -18. 05. 1999 -08. 12. 2000 Tepoxalin -Plough Treatment of pain 30, 50, 100 200 mg/ml -08. 11. 2000 Parte B UK inflammation 39 -210 days -330 days Eurican herpes Merial Dogs Powder plus solvent for -13. 07. 1999 -08. 12. 2000 205 F Vaccine against emulsion for injection -08. 11. 2000 Inactivated canine herpes 1 ml -209 days vaccine 2 -274 days Parte BEMEA/MB/050/00 Relatório Anual 2000 Page 80/88 Estabelecimento dos limites máximos de resíduos para substâncias novas Substância Área terapêutica EMEA/CVMP Comissão -DCI -Espécie -Validação -Enviado à Comissão -Parecer -Data do regulamento -Tempo activo -Jornal Oficial -Tempo inactivo Bismuth subnitrate Bovine -18. 06. 1999 -12. 11. 1999 (extension) -13. 10. 1999 -19. 06. 2000 -113 days -OJ L 145, 20. 06. 2000 -0 Acetyl isovaleryl Porcine -18. 10. 1995 -12. 11. 1999 tylosin tartrate -13. 10. 1999 -19. 06. 2000 -195 days -OJ L 145, 20. 06. 2000 -1260 days Methylprednisolone Bovine -13. 07. 1999 -12. 11. 1999 -13. 10. 1999 -19. 06. 2000 -92 days -OJ L 145, 20. 06. 2000 -0 Deltamethrin Fin fish -09. 12. 1999 -07. 04. 2000 (extension) -08. 03. 2000 -15. 09. 2000 -90 days -OJ L 234, 16. 09. 2000 -0 Tylosin Eggs -09. 11. 1999 -07. 04. 2000 (extension) -08. 03. 2000 -15. 09. 2000 -90 days -OJ L 234, 16. 09. 2000 -0 Dicyclanil Ovine -25. 02. 1997 -07. 04. 2000 -08. 03. 2000 -15. 09. 2000 -281 days -OJ L 234, 16. 09. 2000 -825 days Tilmicosin Rabbit -16. 07. 1999 -12. 11. 1999 (extension) -13. 10. 1999 -20. 10. 2000 -86 days -OJ L 269, 21. 10. 2000 -0 Flumequine Bovine milk turkey -27. 07. 1999 -09. 12. 1999 (extension) -10. 11. 1999 -20. 10. 2000 -89 days -OJ L 269, 21. 10. 2000 -0 Tiamulin Rabbit -14. 10. 1999 -11. 02. 2000 (extension) -12. 01. 2000 -20. 10. 2000 -90 days -OJ L 269, 21. 10. 2000 -0 Dicyclanil Sheep fat -23. 02. 2000 -16. 06. 2000 (modification) -17. 05. 2000 -27. 10. 2000 -84 days -OJ L 276, 28. 10. 2000 -0 Butafosfan Dairy cattle -19. 01. 2000 -19. 05. 2000 (extension) -19. 04. 2000 -27. 10. 2000 -90 days -OJ L 276, 28. 10. 2000 -0 Tilmicosin Bovine milk -22. 02. 1999 -19. 05. 2000 (extension) -19. 04. 2000 -27. 10. 2000 -203 days -OJ L 276, 28. 10. 2000 -210 days Phoxim Ovine -19. 01. 2000 -19. 05. 2000 (extension) -19. 04. 2000 -27. 10. 2000 -90 -OJ L 276, 28. 10. 2000 -0 Flumethrin Ovine -19. 01. 2000 -19. 05. 2000 (extension) -19. 04. 2000 -27. 10. 2000 -90 days -OJ L 276, 28. 10. 2000 -0 Flunixin Equine -23. 03. 2000 -21. 07. 2000 (extension) -21. 06. 2000 -29. 12. 2000 -90 days -OJ L 336, 30. 12. 2000 -0EMEA/MB/050/00 Relatório Anual 2000 Page 81/88 Substância Área terapêutica EMEA/CVMP Comissão -DCI -Espécie -Validação -Enviado à Comissão -Parecer -Data do regulamento -Tempo activo -Jornal Oficial -Tempo inactivo Toltrazuril Porcine -16. 02. 1999 -21. 07. 2000 (extension) -21. 06. 2000 -29. 12. 2000 -206 days -OJ L 336, 30. 12. 2000 -284 days Thiamphenicol Porcine, Ovine, Turkey, -15. 05. 1998 -08. 11. 2000 (extension) Fish -21. 06. 2000 -206 days -562 days Difloxacin Bovine, Porcine -14. 07. 1998 -21. 07. 2000 (extension) -21. 06. 2000 -29. 12. 2000 -205 days -OJ L 336, 30. 12. 2000 -503 days Halofuginone Bovine -10. 12. 1996 -21. 07. 2000 -21. 06. 2000 -29. 12. 2000 -281 days -OJ L 336, 30. 12. 2000 -1008 days Linear dodecyl Bovine -22. 01. 1999 -18. 08. 2000 benzene sulfonic acid -19. 07. 2000 -195 days -321 days Phoxim Ovine -19. 01. 2000 -18. 08. 2000 (extension) -19. 07. 2000 -120 days -o Acetyl isovaleryl Porcine -18. 01. 1995 -18. 02. 2000 tylosin tartrate -13. 09. 2000 -274 days -1790 days Florfenicol Fish -29. 01. 1996 -08. 11. 2000 (extension) -11. 11. 2000 -212 days -1504 days Meloxicam Porcine -07. 09. 2000 -04. 01. 2001 (extension) -06. 12. 2000 -90 days -0 days Tilmicosin Turkey -07. 09. 2000 -04. 01. 2001 z( extension) -06. 12. 2000 -90 days -0 daysEMEA/MB/050/00 Relatório Anual 2000 Page 82/88 Anexo 10 Pareceres do COMP sobre medicamentos órfãos emitidos em 2000 Medicamento Patrocinador Indicação EMEA/CPMP Comissão -Apresentação -Parecer recebido em -Validação -Data da designação -Parecer -Tempo activo Somatropin Ares-Serono AIDS-wasting -28. 04. 2000 -17. 07. 2000 (Europe) Ltd -15. 06. 2000 -08. 08. 2000 -11. 07. 2000 -27 days Treatment of Fabry disease Alpha -TKT Europe-5S -03. 05. 2000 -17. 07. 2000 Galactosidase A AB -15. 06. 2000 -08. 08. 2000 -11. 07. 2000 -27 days Alpha -Genzyme BV Treatment of Fabry disease -12. 05. 2000 -17. 07. 2000 Galactosidase A -15. 06. 2000 -08. 08. 2000 -11. 07. 2000 -27 days Fluorouracil Treatment of glioblastoma Ethypharm S. A. -26. 05. 2000 -18. 09. 2000 -31. 07. 2000 -18. 10. 2000 -13. 09. 2000 -45 days Gemtuzumab Wyeth-Ayerst Treament of acute myeloid leukaemia -07. 06. 2000 -18. 09. 2000 ozogamicin Research -31. 07. 2000 -18. 10. 2000 -13. 09. 2000 -45 days 1, 5 -(Butylimino) -Oxford Treatment of Gaucher disease -07. 06. 2000 -18. 09. 2000 1, 5-dideoxy, D -GlycoSciences -31. 07. 2000 -18. 10. 2000 glucitol Ltd -13. 09. 2000 -45 days N-carbamyl-L -Orphan Europe Treatment of N-acetylglutamate synthetase -02. 05. 2000 -18. 09. 2000 glutamic acid Sarl (NAGS) deficiency -31. 07. 2000 -18. 10. 2000 -13. 09. 2000 -45 days Arsenic trioxide Voisin Consulting Treatment of acute promyelocytic leukaemia -08. 05. 2000 -18. 09. 2000 Sarl -15. 06. 2000 -18. 10. 2000 -13. 09. 2000 -90 days Thalidomide Laboratoires Treatment of erythema nodosum leprosum or -01. 06. 2000 -6. 11. 2000 LAPHAL type II reactions in Hansen" s disease -25. 08. 2000 -29. 12. 2000 -27. 10. 2000 -64 days Anagrelide Shire Treatment of essential thrombocythaemia -31. 05. 2000 -6. 11. 2000 hydrochloride Pharmaceutical -31. 07. 2000 -29. 12. 2000 Development Ltd -27. 10. 2000 -89 days Busulfan Pierre Fabre Intravenous conditioning treatment prior to -09. 06. 2000 -6. 11. 2000 (intravenous use) Médicament hematopoietic progenitor cell transplantation -31. 07. 2000 -29. 12. 2000 -27. 10. 2000 -89 days Nitisinone Swedish Orphan Treatment of tyrosinaemia type 1 -05. 06. 2000 -6. 11. 2000 AB -25. 08. 2000 -29. 12. 2000 -27. 10. 2000 -64 days Treatment of Huntington" s disease Ethyl Laxdale Ltd -05. 06. 2000 -6. 11. 2000 eicosopentaenoate -31. 07. 2000 -29. 12. 2000 -27. 10. 2000 -89 days Iloprost Schering AG Treatment of primary and of the following -10. 05. 2000 -6. 11. 2000 forms of secondary pulmonary hypertension: -31. 07. 2000 -29. 12. 2000 connective tissue disease pulmonary -27. 10. 2000 hypertension, drug-induced pulmonary -89 days hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease and chronic thromboembolic pulmonary hypertension...Treatment of amyotrophic lateral sclerosis... -07. 08. 2000 --25. 08. 2000 -21. 11. 2000 -89 days

OvineEquinePorcinePorcine, Ovine, Turkey, FishBovine, PorcineBovineBovineOvinePorcineFishPorcineTurkeyEMEA/CVMP -Validation -Opinion -Active time -Clockstop -19.01.2000 -19.04.2000 -90 days -0 -23.03.2000 -21.06.2000 -90 days -0 -16.02.1999 -21.06.2000 -206 days -284 days -15.05.1998 -21.06.2000 -206 days -562 days -14.07.1998 -21.06.2000 -205 days -503 days -10.12.1996 -21.06.2000 -281 days -1008 days -22.01.1999 -19.07.2000 -195 days -321 days -19.01.2000 -19.07.2000 -120 days -0 -18.01.1995 -13.09.2000 -274 days -1790 days -29.01.1996 -11.11.2000 -212 days -1504 days -07.09.2000 -06.12.2000 -90 days -0 days -07.09.2000 -06.12.2000 -90 days -0 daysCommission -Sent to Commission -Date of Regulation -Official Journal-19.05.2000 -27.10.2000 -OJ L 276, 28.10.2000-21.07.2000 -29.12.2000 -OJ L 336, 30.12.2000-21.07.2000 -29.12.2000 -OJ L 336, 30.12.2000-08.11.2000-21.07.2000 -29.12.2000 -OJ L 336, 30.12.2000-21.07.2000 -29.12.2000 -OJ L 336, 30.12.2000-18.08.2000-18.08.2000-18.02.2000-08.11.2000-04.01.2001-04.01.200181Annex 10:COMP opinions in 2000 on orphan medicinal productsProductSponsorIndicationEMEA/COMP -Submission -Validation -Opinion -Active timeCommission -Opinion received -Date of DesignationSomatropinAlpha-Galactosidase AAlpha-Galactosidase AFluorouracilGemtuzumab ozogamicin1,5-(Butylimino)-1,5-dideoxy, D-glucitolN-carbamyl-L-glutamic acidArsenic trioxideAres-Serono (Europe) LtdTKT Europe-5S ABGenzyme BVEthypharm S. A.Wyeth-Ayerst ResearchOxford GlycoSciences LtdOrphan Europe SarlVoisin Consulting SarlAIDS-wastingTreatment of Fabry diseaseTreatment of Fabry diseaseTreatment of glioblastomaTreament of acute myeloid leukaemiaTreatment of Gaucher diseaseTreatment of N-acetylglutamate synthetase (NAGS) deficiencyTreatment of acute promyelocytic leukaemia-28.04.2000 -15.06.2000 -11.07.2000 -27 days-03.05.2000 -15.06.2000 -11.07.2000 -27 days-12.05.2000 -15.06.2000 -11.07.2000 -27 days-26.05.2000 -31.07.2000 -13.09.2000 -45 days-07.06.2000 -31.07.2000 -13.09.2000 -45 days-07.06.2000 -31.07.2000 -13.09.2000 -45 days-02.05.2000 -31.07.2000 -13.09.2000 -45 days-08.05.2000 -15.06.2000 -13.09.2000 -90 days-17.07.2000 -08.08.2000-17.07.2000 -08.08.2000-17.07.2000 -08.08.2000-18.09.2000 -18.10.2000-18.09.2000 -18.10.2000-18.09.2000 -18.10.2000-18.09.2000 -18.10.2000-18.09.2000 -18.10.2000ThalidomideLaboratoires LAPHALTreatment of erythema nodosum leprosum or type II reactions in Hansen 's disease-01.06.2000 -25.08.2000 -27.10.2000 -64 days-6.11.2000 -29.12.200082Anagrelide hydrochlorideBusulfan (intravenous use)NitisinoneShire Pharmaceutical Development LtdPierre Fabre MédicamentSwedish Orphan ABTreatment of essential thrombocythaemiaIntravenous conditioning treatment prior to hematopoietic progenitor cell transplantationTreatment of tyrosinaemia type 1-31.05.2000 -31.07.2000 -27.10.2000 -89 days-09.06.2000 -31.07.2000 -27.10.2000 -89 days-05.06.2000 -25.08.2000 -27.10.2000 -64 days-6.11.2000 -29.12.2000-6.11.2000 -29.12.2000-6.11.2000 -29.12.2000EMEA General Report 2000ProductSponsorIndicationEMEA/COMP -Submission -Validation -Opinion -Active timeCommission -Opinion received -Date of DesignationEthyl eicosopentaenoateIloprost------------EMEA General ReportLaxdale LtdSchering AG------------2000