Plan de prelevare şi testare produse medicinale veterinare indigene (RO) Anexa nr. 1. Autorizaţie de comercializare Valabilitate
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1 Anexa nr. 1 Plan de şi testare produse medicinale veterinare indigene (RO) Propamicin UI de nelimitată ANTIBIOTICE S.A. IAŞI ANTIBIOTICE S.A. IAŞI cutii x 50 flacoane x 26 ml DSVSA Bistriţa 10 flacoane x 26 ml 2. Mibazon nelimitată ANTIBIOTICE S.A. IAŞI ANTIBIOTICE S.A. IAŞI 3. Amoxicrid Retard % Inj. 4. Bromex Multi-vita-vet IRAC 6. Tilozina FP nelimitată 7. Enrofloxarom C nelimitată tub x 36 g flacon x 50 ml, 100 ml, 250 ml flacon x 100, 500, 1000 ml, bidon x 5, 10, 20 litri flacon x 10; 20; 50; 100 ml DSVSA Bistriţa DSVSA Călăraşi DSVSA Argeş flacon x 20 ml, 50 ml, 100 ml DSVSA Argeş 8. Alergotrat 3% nelimitată 9. Salvacan P nelimitată COMPANY SA COMPANY SA 10. Colidem nelimitată flacon x 100 DSVSA Caraş- Severin flacon x 10 ml, 20 ml, 50 ml DSVSA Ialomiţa flacon x 1 ml DSVSA Ialomiţa flacoane x 100, 500, 1000 ml, bidoane x 5, 10, 20 l DSVSA Vrancea 5 tuburi x 36 g 3 flacoane x 100 ml 10 flacoane x 10 ml 6 flacoane x 20 ml 4 flacoane x 100 cpr 10 flacoane x 10 ml 20 flacoane x 1 doză 3 flacoane x 100 ml 1
2 de 11. Clorostatic nelimitată 12. Progestin nelimitată 13. Cyper vet nelimitată 14. Penstrep nelimitată 15. Amoxylrom 10% nelimitată 16. Scabatox nelimitată 17. Romivermectin 1% nelimitată 18. Tiforomvac nelimitată 19. Drotavet nelimitată 20. Romavermectin B nelimitată 1% Plus 21. Antidezenter nelimitată 22. Lincomicina FP 11% nelimitată 23. Eritrom nelimitată 24. Microgamaglobulina nelimitată antitetanica 25. Disterom nelimitată flacoane x 7,5 ml; 10 ml; 30 ml cu picurător flacon x 20; 30; 50; 100 flacon x 50 ml, 100 ml flacon x 50 ml, 100 ml, 250 ml DSVSA Braşov DSVSA Braşov DSVSA Buzău DSVSA Galaţi flacon x 20 ml, 50 ml, 100 ml DSVSA Neamţ flacon x 50 ml, 100 ml, 500 DSVSA Sălaj ml, 1000 ml, 5000 ml flacon x 5; 10; 20; 50; 100 ml DSVSA Vaslui flacon x 25; 50; 100; 200; DSVSA Vâlcea 400 flacon x 20 ml DSVSA Alba flacon x 5 ml, 10 ml, 20 ml, DSVSA Alba 50 ml, 100 ml flacon x 50 g, 100 g DSVSA Bihor pungă x 5 g, 10 g, 25 g, 50 g, DSVSA Dâmboviţa 100 g, 200 g, 500 g, 1, sac x 10, 20 pungi x 50 g, 100 g, 1000 g DSVSA Dolj flacoane x 10; 20; 50; 100 ml DSVSA Dolj flacon x 1; 2; 4; 5; 10 DSVSA Bacău 7 flacoane x 7,5 ml 3 flacoane x 50 ml 6 flacoane x 20 ml 3 flacoane x 50 ml 10 flacoane x 25 3 flacoane x 50 g 8 pungi x 10 g 10 flacoane x 10 ml 25 flacoane x 1-5 2
3 de 26. Clortetradem nelimitată 27. Agalaxin forte Oxifuran vitaminizat nelimitată 29. Bisulfim nelimitată (Comprimate) 30. Vermizol A nelimitată 31. Oxitetraciclină FP nelimitată 20% 32. Rompervac ABCD nelimitată 33. Crimectin Inj Lincomix 10% inj Asocilin nelimitată ANTIBIOTICE S.A. IAŞI 36. Auvac nelimitată INSTITUTUL PASTEUR S.A. 37. Enrofloxacina 40% IRAC 38. Borogluconat de calciu 38% nelimitată 39. Calciu-magneziu nelimitată pungă x 10, 25, 50, 100, 500, DSVSA Cluj 1000 g; 5, 10 ; sac x 25, 50 flacon x 20; 50; 100 DSVSA Hunedoara (20, 50, 100 ml) flacon x 50 g, 100 g, 1000 g DSVSA Prahova Cutie din carton cu 2 blistere sau 10 blistere din PVC/Al a cate 10 fiecare flacon x 30, 50, 100 pungi x 100 g, 200 g, 500 g, 1, saci x 20 Flacon x 50, 100, 250 ml DSVSA Vâlcea DSVSA Vâlcea DSVSA Brăila DSVSA Brăila flacon x 50, 100, 250 ml DSVSA Călăraşi flacon x 50, 100, 250 ml DSVSA Călăraşi ANTIBIOTICE S.A. tub x 20 g DSVSA Constanţa IAŞI INSTITUTUL flacon x 10, 25, 50, 100 DSVSA Galaţi PASTEUR S.A. pungi x 5 g, 10 g, 20 g, 50 g, DSVSA Galaţi 100 g, 500 g, 1 ; saci x 5, 10, 20. flacoane x 20; 50; 100; 250; 500 ml flacon x 20 ml, 50 ml, 100 ml, 250 ml 4 pungi x 10 g 10 flacoane x 20 ml 3 flacoane x 50 g 4 cutii x 2 blistere x 10 4 flacoane x 30 cpr 2 pungi x 100 g 10 flacoane x 50 ml 5 tuburi x 20 g 20 flacoane x 25 3
4 de 40. Enroflox inj. 10% Gentamicina FP 10% nelimitată 42. Leptovac IRAC INSTITUTUL PASTEUR S.A. flacon x 50, 100, 250 ml Flacon x 20, 50, 100 ml flacon x 20, 50, 100, 250 ml (10, 25, 50, 125 ) DSVSA Bistriţa DSVSA Bucureşti DSVSA Bucureşti 6 flacoane x 20 ml 10 flacoane x 20 ml 43. Agalaxin nelimitată 44. Paramixovacol nelimitată 45. Canider U nelimitată 46. Columbo spot nelimitată 47. Rombendazol 10% nelimitată 48. Gentocin - doser nelimitată 49. Progesteron FP nelimitată 50. Sulfametoprim nelimitată 51. Biaromvac I nelimitată 52. Pesarii spumante şi nelimitată efervescente cu oxitetraciclina si neomicina flacon x 20; 50; 100 (20, 50, 100 ml) flacon x 10; 20; 50; 100; 200 cutii x 25 g, tuburi x 10; 20; 40 g flacon cu picurător x 5, 10, 25 ml flacon x 100 ml, 250 ml, 500 ml, canistră x 1000 ml flacon x 100 ml, 200 ml cu pompiţă dozatoare iulie 2016 DSVSA Argeş DSVSA Argeş DSVSA Covasna DSVSA Ialomiţa flacoane x 10; 20; 50; 100 ml DSVSA Mureş flacon x 20, 30, 50, 100 DSVSA Teleorman flacon x 50; 100; 250; 500; DSVSA Bihor 1000; 2000; 3000; 5000 flacon x 25, 50, 100 pesarii DSVSA Botoşani 10 flacoane x 20 ml 13 flacoane x 10 4 tuburi x 10 g 7 flacoane x 5 ml 2 flacoane x 100 ml 3 flacoane x 100 ml 10 flacoane x 10 ml 6 flacoane x 20 cpr 14 flacoane x 50 5 flacoane x 25 pesarii 4
5 de DSVSA Mehedinţi DSVSA Olt 53. Trankilrom nelimitată flacon x 10 ml, 20 ml, 50 ml, 100 ml 54. Agavac nelimitată INSTITUTUL flacon x 50, 100 ml PASTEUR SA 55. Tilodem nelimitată pungă x 10, 25, 50, 100, 500 g; 1, 5, 10 ; sac x 25, Clortimulin nelimitată pungă x 50 g, 100 g, 250 g, DSVSA Sibiu 500 g, 1, sac x 10, Tyloplus Inj Florfenidem nelimitată 59. Tiadem 10% nelimitată 60. Neoxivit IRAC 61. Florcrid inj Mediodine unguent nelimitată 63. Enroflox inj. 5% Tiagen 80% nelimitată 65. Propamicin nelimitată ANTIBIOTICE UI S.A. IAŞI 66. Iver-mite otic nelimitată ANTIBIOTICE S.A. IAŞI flacon x 50 ml, 100 ml, 250 ml pungă x 10, 25, 50, 100, 500, 1000 g; 5, 10 ; sac 25, 50 pungă x 10 g, 25 g, 50 g, 100 g, 500 g, 1000 g, 5, 10, sac x 25, 50 pungi x 50 g, 100 g, 200 g, 500 g, 1, saci x 5, 10, 25 flacon x 50, 100, 250 ml tub x 10, 20, 60, 200 g flacon x 50, 100, 250 ml pungi x 100 g; 1 ; 5 ; saci x 10 ; 25 ; 50 cutii x 50; 100 flacoane x 10 ml flacon cu picurător x 7,5 ml; 30 ml DSVSA Brăila DSVSA Teleorman DSVSA Alba DSVSA Călăraşi DSVSA Călăraşi DSVSA Dolj DSVSA Hunedoara 10 flacoane x 10 ml 10 flacoane x 50 ml 5 pungi x 10 g 4 pungi x 10 g 8 pungi x 10 g 4 tuburi x 10 ml 3 pungi x 100 g 15 flacoane x 10 ml 5 flacoane x 7,5 ml 5
6 de 67. Ivermectina FP nelimitată 68. Premix medicamentat pentru pui 69. Germostop cicatrizant IRAC nelimitată 70. Mastiker E nelimitată 71. Prazytel nelimitată 72. Varatraz Pet-Spot solutie spoton pentru câini în greutate de Pet-Spot solutie spoton pentru câini în greutate de Pet-Spot solutie spoton pentru caini in greutate de Pet-Spot solutie spoton pentru câini în greutate de nelimitată nelimitată nelimitată nelimitată cutii x 2 sau 10 blistere x 10 pungi x 1 ; 2 Flacoane x 50; 100; 250; 500 g. seringa x 6 ml Cutii din carton cu 2 blistere sau 10 blistere din PVC/Al a cate 10 fiecare flacon x 10 ml + 50 benzi de carton fumigen pipetă x 0,4 ml pipetă x 0,7 ml pipetă x 1 ml pipetă x 2 ml DSVSA Timiş DSVSA Buzău Decembrie 2016 DSVSA Galaţi Decembrie 2016 DSVSA Ialomiţa Decembrie 2016 Decembrie Antipoux-Van Forte nelimitată VANELLI VANELLI flacon x 75 g, 100 g, 200 g DSVSA Arad 78. Enteroxin 40% nelimitată flacon x 10 ml, 20 ml, 50 ml, DSVSA Vrancea 100 ml 5 cutii x 2 blistere x 10 1 pungă x 1 3 flacoane x 50 g 7 seringi x 6 ml 5 cutii x 2 blistere x 10 2 flacoane x 10 ml + 50 benzi de carton fumigen 60 pipete x 0,4 ml 33 pipete x 0,7 ml 21 pipete x 1 ml 15 pipete x 2 ml 4 flacoane x 75 g 8 flacoane x 10 ml 6
7 de 79. Enteroxin 5% nelimitată 80. Albastru de metilen 2% 81. Romoxibendazol nelimitată 15% 82. Tilozina nelimitată flacon x 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml DSVSA Timiş nelimitată VANELLI VANELLI flacon x 100 ml, 1000 ml DSVSA Sibiu pungă x 100, 250, 500, 1000 DSVSA Mureş g DSVSA Brăila 83. Enteroxin 12,5% nelimitată 84. Colidem nelimitată 85. Amoxidem 50% nelimitată 86. Neocen 40% nelimitată pungi x 50 g, 100 g, 250 g, 500 g, 1, sac x 10, 20 flacon x 50 ml, 100 ml, 250 ml, 500 ml, 1 litru; bidon x 2,5 litri, 5 litri DSVSA Dâmboviţa pungă x 10, 25, 50, 100, 500, DSVSA Iaşi 1000 g; 5, 10 ; sac x 25, 50 pungă x 10 g, 25 g, 50 g, 100 g, 500 g, 1000 g, 5, 10, sac x 25, 50 DSVSA Iaşi pungi x 50 g; 100 g; 1 ; 5 DSVSA Sălaj ; saci x 10 ; 25 ; 50 4 flacoane x 50 ml 2 flacoane x 100 ml 2 pungi x 100 g 3 flacoane x 50 ml 87. Colicrid pulv. 50% nelimitată 88. Enteroxin nelimitată pungi x 25 g, 50 g, 100 g, 500 g, 1, 5, sac x 10, 25, 50 flacon x 20, 30, 50, Antipoux-van VANELLI VANELLI flacon de 160 ml cu 75 g pulbere 90. Oxicrid pulv. 40% nelimitată pungă x 25 g, 50 g, 100 g, 500 g, 1, 5, sac x 10, 25, 50. DSVSA Bistriţa DSVSA Alba 4 pungi x 25 g 4 flacoane x 100 DSVSA Alba 2 flacoane x 160 ml DSVSA Dâmboviţa 4 pungi x 25 g 7
8 91. Oxitetraciclina FP 60% de IRAC 92. Gentamicina FP 50% nelimitată 93. Eqvamec P nelimitată 94. Cribendazol 2,5% Helmizol Plus IRAC 96. Oxidem nelimitată pungi x 5 g, 10 g, 20 g, 50 g, 100 g, 500 g, 1. Saci x 5, 10, 20. pungi x 50 g; 100 g; 250 g; 500 g; 1 seringă x 6 ml flacon x 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml, 5 litri, 10 litri, 20 litri flacon x 10, 20, 50, 100 boluri DSVSA Bacău DSVSA Prahova DSVSA Mureş DSVSA Bistriţa DSVSA Iaşi pungă x 10, 25, 50, 100, 500, DSVSA Iaşi 1000 g; 5, 10 ; sac x 25, Noredon F nelimitată VANELLI VANELLI plic x 50 g, 100 g, 1000 g DSVSA Olt 98. Oxitetraciclina 40% IRAC pungi x 5 g, 10 g, 20 g, 50 g, DSVSA Bihor 100 g, 500 g, 1. Saci x 5, 10, Neomicina FP 40% nelimitată 100. Prazicest Lincomicina FP 60% nelimitată pungi x 5 g, 10 g, 20 g, 50 g, 100 g, 500 g, 1, saci x 5, 10, 20. flacon x 10 ml, 20 ml, 50 ml, 100 ml, fiole x 1 ml, 2 ml, 5 ml pungi x 5 g, 10 g, 20 g, 50 g, 100 g, 500 g, 1, saci x 5, 10, 20. DSVSA Satu Mare DSVSA Satu Mare DSVSA Vrancea 6 seringi x 6 ml 3 flacoane x 50 ml 3 flacoane x plicuri x 50 g 8 flacoane x 10 ml 8
9 de 102. Ampicilina FP 60% nelimitată 103. Helmizol nelimitată 104. Colistirom I nelimitată 105. Eritromicina 10% nelimitată 106. Ecvirom IRAC pungi x 5 g, 10 g, 20 g, 50 g, 100 g, 500 g, 1, saci x 5, 10, 20. flacon x 10, 20, 50, 100 boluri DSVSA Prahova DSVSA Dolj 10 flacoane x 10 boluri flacon x 50 ml, 100 ml DSVSA Mureş flacon x 20 ml, 50 ml, 100 ml DSVSA Tulcea 6 flacoane x 20 ml seringi x 20 ml; 50 ml DSVSA Dâmboviţa 3 seringi x 20 ml 107. Rombendazol Plus nelimitată flacon x 100 ml, 250 ml, 500 DSVSA Mureş ml, 1000 ml 108. Oxirom nelimitată pungi x 50 g, 100 g, 1000 g DSVSA Arad 109. Noredon C nelimitată VANELLI VANELLI flacoane x 25 cpr., 100 cpr., DSVSA Iaşi 1000 cpr Rombendazol F nelimitată flacon x 100 DSVSA Bacău 111. Rometronidazol nelimitată pungă x 50 g DSVSA Botoşani 112. Pyratel CD nelimitată INSTITUTUL INSTITUTUL flacon x 30 ml, 60 ml, 100 DSVSA Bacău PASTEUR SA PASTEUR SA ml, 500 ml, 1 litru 113. Levamisol nelimitată flacon x 20 ml, 50 ml, 100 ml DSVSA Mureş 114. Bisulfim nelimitată Pungi x 50 g, 100 g, 250 g, DSVSA Giurgiu (Premix 500 g, 1 Kg, sac x 10 Kg, 20 medicamentat) Kg 115. Cafeina nelimitată INSTITUTUL INSTITUTUL flacon x 10 ml, 20 ml, 50 ml, DSVSA Giurgiu natriumbenzoica 25% PASTEUR SA 116. Gentocin plus nelimitată PASTEUR SA 100 ml flacon x 7,5 ml cu picurător DSVSA Dâmboviţa 2 flacoane x 100 ml 3 flacoane x flacoane x flacoane x 30 ml 5 flacoane x 20 ml 8 flacoane x 10 ml 8 flacoane x 7,5 ml 9
10 de 117. Gentocin oftalmic nelimitată 118. Avipox gal şi diluantul corespunzător nelimitată COMPANY SA numărului de 119. Romporpox nelimitată COMPANY S.A 120. Birovac H nelimitată COMPANY S.A 121. Bronvac nelimitată INSTITUTUL PASTEUR SA 122. Ruvac nelimitată INSTITUTUL PASTEUR SA 123. Mamivac nelimitată 124. Amoxineovit C nelimitată, 125. Noredon C nelimitată VANELLI, România IRAC = în curs de reînnoire a i de flacon x 7,5 ml cu picurător COMPANY SA COMPANY S.A INSTITUTUL PASTEUR SA, VANELLI, România flacon x 50, 100, 250, 500, 1000, 2000, 3000 flacoane x 10; 25; 50; 100 cu diluantul corespunzător flacoane x 25; 50; 100; 250; 500; 1000; 2000; 5000 flacon x 100, 500, 1000, 2000, 3000, 5000 Flacon x 5, 10, 25, 50, 100, 200 flacoane x 50 ml, 100 ml (15, 33 ) flacon x 50 cpr., 100 cpr., blister x 10 cpr. flacoane x 25 cpr., 100 cpr., 1000 cpr. DSVSA Mehedinţi DSVSA Braşov DSVSA Constanţa DSVSA Neamţ DSVSA Neamţ DSVSA Bucureşti DSVSA Bucureşti DSVSA Vaslui DSVSA Iaşi 8 flacoane x 7,5 ml 13 flacoane x 50 + diluantul corespunzător 13 flacoane x flacoane x flacoane x flacoane x 5 10 flacoane x 50 ml (33 ) 6 flacoane x flacoane x 25 NOTĂ: * Produsele medicinale veterinare au fost incluse în Planul de după confirmarea de către ii autorizaţiilor de a disponibilităţii acestora pe piaţa din România în cursul anului Produsele medicinale veterinare pentru care nu s-au raportat vânzări în cursul anului 2015 de către D.S.V.S.A.-urile judeţene, respectiv a municipiului Bucureşti au fost repartizate pentru în anul **Frecvenţa prelevării a fost stabilită pe baza indexului de risc atribuit/produs, iar desemnarea D.S.V.S.A. s-a realizat pe baza volumului de vânzări/produs pe teritoriul judeţului respectiv/anul precedent. 10
11 *** Probele trebuie să fie prelevate cu cel puţin 3 luni înainte de expirarea produsului (valabilitatea înscrisă pe eticheta produsului) şi să provină din acelaşi lot (serie). prelevată reprezintă cantitatea minimă necesară pentru verificarea parametrilor calitativi ai produsului, conform cerinţelor Farmacopeei Europene. În cazul în care produsul medicinal veterinar nu este disponibil în ambalajul de dimensiunea specificată în coloana 9, acesta se va preleva din mărimea de ambalaj existentă, păstrându-se numărul de flacoane specificat. În cazul în care se efectuează a de probe de produse medicinale veterinare sub formă de pulberi ambalate în cutii, galeţi, saci, etc. (peste 300 g) sau sub formă de soluţii orale ambalate în flacoane (peste 1 litru), cantitatea prelevată va fi de 4 probe x minimum 50 g/probă, respectiv 4 probe x minimum 100 ml/probă, iar operaţiunea de se va efectua astfel încât să se prevină contaminarea produsului. Produsele medicinale veterinare prelevate în anul 2015 şi pentru care au fost înregistrate defecte de calitate, au fost repartizate pentru din nou în anul Produsele medicinale veterinare prelevate în 2014 pentru care au fost înregistrate defecte de calitate şi nu au fost prelevate în anul 2015, au fost repartizate pentru în anul
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