Alerta Farmacéutica R_35/2016 - Vacunas individualizadas de uso parenteral: Alergol Depot y Alergopol

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Última actualització: 28/12/2016

Puede consultar esta información en formato pdf

Referencia:
DICM/CONT/IV
Nº alerta:
R_35/2016
Fecha:
27 de diciembre de 2016
Producto:
Medicamento
Marca comercial y presentación:
Vacunas individualizadas de uso parenteral: Alergol Depot y Alergopol
Lotes y fecha de caducidad:
Se indica en el anexo el número de tratamiento, que es el dato que figura en el envase del medicamento. Ver anexo (listado de medicamentos afectados, que consta de 17 páginas)
Fecha de caducidad:
Ver anexo
Responsable de comercialización:
EUROFAR ALERGI S.L.
Laboratorio fabricante:
EUROFAR ALERGI S.L.
INMUNOTEK, S.L., instalaciones de San Sebastián de los Reyes (fabricante del producto intermedio)
Domicilio social del responsable del producto:
Polígono Industrial La Estación, C/ Grecia 4 , 28971, Griñón (Madrid)
Descripción del defecto:
Incumplimiento de normas de correcta fabricación del fabricante de producto intermedio estéril (INMUNOTEK, S.L. instalación de San Sebastián de los Reyes) por ello, no puede garantizarse la esterilidad de los medicamentos incluidos en el anexo.
Información sobre la distribución:
Cadena de distribución y dispensación
Clasificación de los defectos:
Clase 1
Medidas cautelares adoptadas:
Retirada del mercado de todas las unidades distribuidas de los tratamientos de vacunas individualizadas de uso parenteral incluidas en el anexo y devolución al laboratorio por los cauces habituales
Actuaciones a realizar por las CCAA:
Seguimiento de la retirada

Se informa que la compañía ha proporcionado el siguiente número de atención telefónica para la gestión de la alerta farmacéutica R_35/2016.

  • Telf.: 653628191

AGENCIA ESPAÑOLA DE MEDICAMENTOS
Y PRODUCTOS SANITARIOS

Anexo

DENOMINACIÓNNº DE TRATAMIENTOFECHA DE FABRICACIÓNFECHA DE CADUCIDAD
Alergol Depot1113828/12/2015dic-16
Alergol Depot1193528/12/2015dic-16
Alergol Depot1193628/12/2015dic-16
Alergol Depot1193728/12/2015dic-16
Alergol Depot1193828/12/2015dic-16
Alergol Depot1193928/12/2015dic-16
Alergol Depot1047728/12/2015dic-16
Alergol Depot1194504/01/2016ene-17
Alergol Depot420104/01/2016ene-17
Alergol Depot1194804/01/2016ene-17
Alergol Depot946104/01/2016ene-17
Alergol Depot1043404/01/2016ene-17
Alergol Depot1048204/01/2016ene-17
Alergol Depot1168004/01/2016ene-17
Alergol Depot1194004/01/2016ene-17
Alergol Depot1194104/01/2016ene-17
Alergol Depot1194204/01/2016ene-17
Alergol Depot1194304/01/2016ene-17
Alergol Depot1194404/01/2016ene-17
Alergol Depot1194604/01/2016ene-17
Alergol Depot1149904/01/2016ene-17
Alergol Depot1194704/01/2016ene-17
Alergol Depot1144511/01/2016ene-17
Alergol Depot1149511/01/2016ene-17
Alergol Depot1096211/01/2016ene-17
Alergol Depot1139611/01/2016ene-17
Alergol Depot1018811/01/2016ene-17
Alergol Depot943911/01/2016ene-17
Alergol Depot1148211/01/2016ene-17
Alergol Depot1194911/01/2016ene-17
Alergol Depot1195011/01/2016ene-17
Alergol Depot1195111/01/2016ene-17
Alergol Depot1195211/01/2016ene-17
Alergol Depot1195311/01/2016ene-17
Alergol Depot1195411/01/2016ene-17
Alergol Depot1195511/01/2016ene-17
Alergol Depot1195611/01/2016ene-17
Alergol Depot1195711/01/2016ene-17
Alergol Depot1195811/01/2016ene-17
Alergol Depot1120911/01/2016ene-17
Alergol Depot992618/01/2016ene-17
Alergol Depot1086018/01/2016ene-17
Alergol Depot968518/01/2016ene-17
Alergol Depot555618/01/2016ene-17
Alergol Depot1063318/01/2016ene-17
Alergol Depot920518/01/2016ene-17
Alergol Depot1138818/01/2016ene-17
Alergol Depot588918/01/2016ene-17
Alergol Depot1101818/01/2016ene-17
Alergol Depot1195918/01/2016ene-17
Alergol Depot1196018/01/2016ene-17
Alergol Depot1196118/01/2016ene-17
Alergol Depot1196218/01/2016ene-17
Alergol Depot1196318/01/2016ene-17
Alergol Depot1196418/01/2016ene-17
Alergol Depot1196518/01/2016ene-17
Alergol Depot1196618/01/2016ene-17
Alergol Depot1196718/01/2016ene-17
Alergol Depot1196818/01/2016ene-17
Alergol Depot1196918/01/2016ene-17
Alergol Depot1197018/01/2016ene-17
Alergol Depot1197118/01/2016ene-17
Alergol Depot1197218/01/2016ene-17
Alergol Depot1197318/01/2016ene-17
Alergol Depot1136618/01/2016ene-17
Alergol Depot1046718/01/2016ene-17
Alergol Depot1167925/01/2016ene-17
Alergol Depot1100025/01/2016ene-17
Alergol Depot1035925/01/2016ene-17
Alergol Depot616425/01/2016ene-17
Alergol Depot1117325/01/2016ene-17
Alergol Depot1197425/01/2016ene-17
Alergol Depot1197525/01/2016ene-17
Alergol Depot1197625/01/2016ene-17
Alergol Depot1197725/01/2016ene-17
Alergol Depot1197825/01/2016ene-17
Alergol Depot1197925/01/2016ene-17
Alergol Depot1198025/01/2016ene-17
Alergol Depot1198125/01/2016ene-17
Alergol Depot1102725/01/2016ene-17
Alergol Depot1198225/01/2016ene-17
Alergol Depot1198325/01/2016ene-17
Alergol Depot1198425/01/2016ene-17
Alergol Depot587701/02/2016feb-17
Alergol Depot1140501/02/2016feb-17
Alergol Depot1000501/02/2016feb-17
Alergol Depot1151701/02/2016feb-17
Alergol Depot1066101/02/2016feb-17
Alergol Depot1129801/02/2016feb-17
Alergol Depot1198501/02/2016feb-17
Alergol Depot1198601/02/2016feb-17
Alergol Depot1198701/02/2016feb-17
Alergol Depot1198801/02/2016feb-17
Alergol Depot1198901/02/2016feb-17
Alergol Depot1199001/02/2016feb-17
Alergol Depot1199101/02/2016feb-17
Alergol Depot1199201/02/2016feb-17
Alergol Depot1199301/02/2016feb-17
Alergol Depot1199401/02/2016feb-17
Alergol Depot1199501/02/2016feb-17
Alergol Depot888208/02/2016feb-17
Alergol Depot1164908/02/2016feb-17
Alergol Depot1148008/02/2016feb-17
Alergol Depot1137608/02/2016feb-17
Alergol Depot1199608/02/2016feb-17
Alergol Depot1199708/02/2016feb-17
Alergol Depot1199808/02/2016feb-17
Alergol Depot1199908/02/2016feb-17
Alergol Depot1200008/02/2016feb-17
Alergol Depot1200108/02/2016feb-17
Alergol Depot1200208/02/2016feb-17
Alergol Depot1200308/02/2016feb-17
Alergol Depot1200408/02/2016feb-17
Alergol Depot1200508/02/2016feb-17
Alergol Depot1048908/02/2016feb-17
Alergol Depot1116508/02/2016feb-17
Alergol Depot1151908/02/2016feb-17
Alergol Depot1147308/02/2016feb-17
Alergol Depot1200608/02/2016feb-17
Alergol Depot1200708/02/2016feb-17
Alergol Depot1200808/02/2016feb-17
Alergol Depot1200908/02/2016feb-17
Alergol Depot1118715/02/2016feb-17
Alergol Depot763415/02/2016feb-17
Alergol Depot1150215/02/2016feb-17
Alergol Depot1201015/02/2016feb-17
Alergol Depot1201115/02/2016feb-17
Alergol Depot1201215/02/2016feb-17
Alergol Depot1201315/02/2016feb-17
Alergol Depot1201415/02/2016feb-17
Alergol Depot1201515/02/2016feb-17
Alergol Depot1201615/02/2016feb-17
Alergol Depot1201715/02/2016feb-17
Alergol Depot1201815/02/2016feb-17
Alergol Depot922722/02/2016feb-17
Alergol Depot1109122/02/2016feb-17
Alergol Depot1201922/02/2016feb-17
Alergol Depot1202022/02/2016feb-17
Alergol Depot1202122/02/2016feb-17
Alergol Depot1202222/02/2016feb-17
Alergol Depot1202322/02/2016feb-17
Alergol Depot1202422/02/2016feb-17
Alergol Depot1093122/02/2016feb-17
Alergol Depot1155322/02/2016feb-17
Alergol Depot1202522/02/2016feb-17
Alergol Depot1202622/02/2016feb-17
Alergol Depot1202722/02/2016feb-17
Alergol Depot1202822/02/2016feb-17
Alergol Depot1202922/02/2016feb-17
Alergol Depot1203022/02/2016feb-17
Alergol Depot1138022/02/2016feb-17
Alergol Depot1203122/02/2016feb-17
Alergol Depot1148729/02/2016feb-17
Alergol Depot1099429/02/2016feb-17
Alergol Depot1032429/02/2016feb-17
Alergol Depot1095329/02/2016feb-17
Alergol Depot1121729/02/2016feb-17
Alergol Depot922129/02/2016feb-17
Alergol Depot1158029/02/2016feb-17
Alergol Depot1203229/02/2016feb-17
Alergol Depot1203329/02/2016feb-17
Alergol Depot1203429/02/2016feb-17
Alergol Depot1203529/02/2016feb-17
Alergol Depot1203629/02/2016feb-17
Alergol Depot1203729/02/2016feb-17
Alergol Depot1203829/02/2016feb-17
Alergol Depot1203929/02/2016feb-17
Alergol Depot1204029/02/2016feb-17
Alergol Depot1204129/02/2016feb-17
Alergol Depot1204229/02/2016feb-17
Alergol Depot1204329/02/2016feb-17
Alergol Depot1108507/03/2016mar-17
Alergol Depot1075907/03/2016mar-17
Alergol Depot1204407/03/2016mar-17
Alergol Depot1204507/03/2016mar-17
Alergol Depot1204607/03/2016mar-17
Alergol Depot1204707/03/2016mar-17
Alergol Depot1204807/03/2016mar-17
Alergol Depot1204907/03/2016mar-17
Alergol Depot1205007/03/2016mar-17
Alergol Depot1205107/03/2016mar-17
Alergol Depot1205207/03/2016mar-17
Alergol Depot1181214/03/2016mar-17
Alergol Depot1185414/03/2016mar-17
Alergol Depot1154414/03/2016mar-17
Alergol Depot1205314/03/2016mar-17
Alergol Depot1205414/03/2016mar-17
Alergol Depot1205514/03/2016mar-17
Alergol Depot1205614/03/2016mar-17
Alergol Depot1205714/03/2016mar-17
Alergol Depot1205814/03/2016mar-17
Alergol Depot1205914/03/2016mar-17
Alergol Depot1142021/03/2016mar-17
Alergol Depot624421/03/2016mar-17
Alergol Depot1180921/03/2016mar-17
Alergol Depot1145821/03/2016mar-17
Alergol Depot1084721/03/2016mar-17
Alergol Depot742721/03/2016mar-17
Alergol Depot1206021/03/2016mar-17
Alergol Depot1206121/03/2016mar-17
Alergol Depot1206221/03/2016mar-17
Alergol Depot1206321/03/2016mar-17
Alergol Depot1206421/03/2016mar-17
Alergol Depot1206521/03/2016mar-17
Alergol Depot1206621/03/2016mar-17
Alergol Depot1206721/03/2016mar-17
Alergol Depot1206821/03/2016mar-17
Alergol Depot1180728/03/2016mar-17
Alergol Depot1122428/03/2016mar-17
Alergol Depot1076228/03/2016mar-17
Alergol Depot1206928/03/2016mar-17
Alergol Depot1207028/03/2016mar-17
Alergol Depot1207128/03/2016mar-17
Alergol Depot1207228/03/2016mar-17
Alergol Depot1131328/03/2016mar-17
Alergol Depot786304/04/2016abr-17
Alergol Depot1208304/04/2016abr-17
Alergol Depot1111904/04/2016abr-17
Alergol Depot1207304/04/2016abr-17
Alergol Depot1207404/04/2016abr-17
Alergol Depot1207504/04/2016abr-17
Alergol Depot1207604/04/2016abr-17
Alergol Depot1207704/04/2016abr-17
Alergol Depot1207804/04/2016abr-17
Alergol Depot1207904/04/2016abr-17
Alergol Depot1067404/04/2016abr-17
Alergol Depot1112304/04/2016abr-17
Alergol Depot1175004/04/2016abr-17
Alergol Depot1208004/04/2016abr-17
Alergol Depot1208104/04/2016abr-17
Alergol Depot1208204/04/2016abr-17
Alergol Depot761504/04/2016abr-17
Alergol Depot1064504/04/2016abr-17
Alergol Depot1118204/04/2016abr-17
Alergol Depot1152311/04/2016abr-17
Alergol Depot1021911/04/2016abr-17
Alergol Depot1034511/04/2016abr-17
Alergol Depot1150511/04/2016abr-17
Alergol Depot1009811/04/2016abr-17
Alergol Depot1149811/04/2016abr-17
Alergol Depot963211/04/2016abr-17
Alergol Depot1208411/04/2016abr-17
Alergol Depot1208511/04/2016abr-17
Alergol Depot1208611/04/2016abr-17
Alergol Depot1208711/04/2016abr-17
Alergol Depot1208811/04/2016abr-17
Alergol Depot1152211/04/2016abr-17
Alergol Depot1072311/04/2016abr-17
Alergol Depot1208911/04/2016abr-17
Alergol Depot1209011/04/2016abr-17
Alergol Depot1162418/04/2016abr-17
Alergol Depot1158218/04/2016abr-17
Alergol Depot1073918/04/2016abr-17
Alergol Depot1074418/04/2016abr-17
Alergol Depot1159018/04/2016abr-17
Alergol Depot1159618/04/2016abr-17
Alergol Depot1080618/04/2016abr-17
Alergol Depot1209118/04/2016abr-17
Alergol Depot1209218/04/2016abr-17
Alergol Depot1209318/04/2016abr-17
Alergol Depot1209418/04/2016abr-17
Alergol Depot1209518/04/2016abr-17
Alergol Depot1209618/04/2016abr-17
Alergol Depot1209718/04/2016abr-17
Alergol Depot1209818/04/2016abr-17
Alergol Depot1186418/04/2016abr-17
Alergol Depot1158418/04/2016abr-17
Alergol Depot1155618/04/2016abr-17
Alergol Depot1209918/04/2016abr-17
Alergol Depot1210018/04/2016abr-17
Alergol Depot1210118/04/2016abr-17
Alergol Depot1210218/04/2016abr-17
Alergol Depot1210318/04/2016abr-17
Alergol Depot1210418/04/2016abr-17
Alergol Depot1210518/04/2016abr-17
Alergol Depot1210618/04/2016abr-17
Alergol Depot1156118/04/2016abr-17
Alergol Depot1169325/04/2016abr-17
Alergol Depot1177125/04/2016abr-17
Alergol Depot1177225/04/2016abr-17
Alergol Depot1182225/04/2016abr-17
Alergol Depot1210725/04/2016abr-17
Alergol Depot1210825/04/2016abr-17
Alergol Depot1210925/04/2016abr-17
Alergol Depot1211025/04/2016abr-17
Alergol Depot1146325/04/2016abr-17
Alergol Depot1211125/04/2016abr-17
Alergol Depot1211225/04/2016abr-17
Alergol Depot1211325/04/2016abr-17
Alergol Depot1211425/04/2016abr-17
Alergol Depot1211525/04/2016abr-17
Alergol Depot1211625/04/2016abr-17
Alergol Depot1211725/04/2016abr-17
Alergol Depot1211825/04/2016abr-17
Alergol Depot1045125/04/2016abr-17
Alergol Depot1131703/05/2016may-17
Alergol Depot1212703/05/2016may-17
Alergol Depot1212803/05/2016may-17
Alergol Depot1212903/05/2016may-17
Alergol Depot1213509/05/2016may-17
Alergol Depot1071609/05/2016may-17
Alergol Depot929709/05/2016may-17
Alergol Depot1214216/05/2016may-17
Alergol Depot1214116/05/2016may-17
Alergol Depot1214416/05/2016may-17
Alergol Depot1158916/05/2016may-17
Alergol Depot1154216/05/2016may-17
Alergol Depot1167816/05/2016may-17
Alergol Depot1215123/05/2016may-17
Alergol Depot1216130/05/2016may-17
Alergol Depot1216906/06/2016jun-17
Alergol Depot636906/06/2016jun-17
Alergol Depot1164206/06/2016jun-17
Alergol Depot1217413/06/2016jun-17
Alergol Depot581113/06/2016jun-17
Alergol Depot1217713/06/2016jun-17
Alergol Depot1217313/06/2016jun-17
Alergol Depot1218720/06/2016jun-17
Alergol Depot1218120/06/2016jun-17
Alergol Depot1218520/06/2016jun-17
Alergol Depot1218220/06/2016jun-17
Alergol Depot1219627/06/2016jun-17
Alergol Depot1219527/06/2016jun-17
Alergol Depot1220727/06/2016jun-17
Alergol Depot1220204/07/2016jul-17
Alergol Depot1107104/07/2016jul-17
Alergol Depot1220804/07/2016jul-17
Alergol Depot1222111/07/2016jul-17
Alergol Depot1184411/07/2016jul-17
Alergol Depot1221411/07/2016jul-17
Alergol Depot1221711/07/2016jul-17
Alergol Depot1116218/07/2016jul-17
Alergol Depot1222518/07/2016jul-17
Alergol Depot995818/07/2016jul-17
Alergol Depot1222822/07/2016jul-17
Alergol Depot1223022/07/2016jul-17
Alergol Depot1087501/08/2016ago-17
Alergol Depot1196401/08/2016ago-17
Alergol Depot1224308/08/2016ago-17
Alergol Depot1121508/08/2016ago-17
Alergol Depot1224608/08/2016ago-17
Alergol Depot1161208/08/2016ago-17
Alergol Depot1175608/08/2016ago-17
Alergol Depot1223908/08/2016ago-17
Alergol Depot1225429/08/2016ago-17
Alergol Depot1225529/08/2016ago-17
Alergol Depot1079829/08/2016ago-17
Alergol Depot1064012/09/2016sep-17
Alergol Depot1195312/09/2016sep-17
Alergol Depot1227019/09/2016sep-17
Alergol Depot1227219/09/2016sep-17
Alergol Depot1227319/09/2016sep-17
Alergol Depot1073819/09/2016sep-17
Alergol Depot1146726/09/2016sep-17
Alergol Depot1194926/09/2016sep-17
Alergol Depot1227926/09/2016sep-17
Alergol Depot1228126/09/2016sep-17
Alergol Depot1228226/09/2016sep-17
Alergol Depot1228926/09/2016sep-17
Alergol Depot1229526/09/2016sep-17
Alergol Depot1230103/10/2016oct-17
Alergol Depot1038003/10/2016oct-17
Alergol Depot1230403/10/2016oct-17
Alergol Depot1230503/10/2016oct-17
Alergol Depot1191203/10/2016oct-17
Alergol Depot1173903/10/2016oct-17
Alergol Depot1230603/10/2016oct-17
Alergol Depot1137710/10/2016oct-17
Alergol Depot1032310/10/2016oct-17
Alergol Depot1230810/10/2016oct-17
Alergol Depot1227710/10/2016oct-17
Alergol Depot1231717/10/2016oct-17
Alergol Depot1231917/10/2016oct-17
Alergol Depot1232017/10/2016oct-17
Alergol Depot1232724/10/2016oct-17
Alergol Depot1233124/10/2016oct-17
Alergol Depot1233224/10/2016oct-17
Alergol Depot1075928/10/2016oct-17
Alergol Depot1233928/10/2016oct-17
Alergol Depot1234028/10/2016oct-17
Alergol Depot1234128/10/2016oct-17
Alergol Depot1119407/11/2016nov-17
Alergol Depot1234507/11/2016nov-17
Alergol Depot1234607/11/2016nov-17
Alergol Depot1234907/11/2016nov-17
Alergol Depot1235407/11/2016nov-17
Alergol Depot1189107/11/2016nov-17
Alergol Depot1123214/11/2016nov-17
Alergol Depot1236314/11/2016nov-17
Alergol Depot1166721/11/2016nov-17
Alergol Depot1192021/11/2016nov-17
Alergol Depot1158121/11/2016nov-17
Alergol Depot1237128/11/2016nov-17
Alergol Depot1237728/11/2016nov-17
Alergopol392028/12/2015dic-16
Alergopol437028/12/2015dic-16
Alergopol437128/12/2015dic-16
Alergopol437228/12/2015dic-16
Alergopol437328/12/2015dic-16
Alergopol437428/12/2015dic-16
Alergopol437528/12/2015dic-16
Alergopol366828/12/2015dic-16
Alergopol56328/12/2015dic-16
Alergopol437628/12/2015dic-16
Alergopol437728/12/2015dic-16
Alergopol126604/01/2016ene-17
Alergopol369804/01/2016ene-17
Alergopol372104/01/2016ene-17
Alergopol414404/01/2016ene-17
Alergopol437804/01/2016ene-17
Alergopol437904/01/2016ene-17
Alergopol438004/01/2016ene-17
Alergopol438104/01/2016ene-17
Alergopol438204/01/2016ene-17
Alergopol438304/01/2016ene-17
Alergopol398704/01/2016ene-17
Alergopol438404/01/2016ene-17
Alergopol438504/01/2016ene-17
Alergopol122011/01/2016ene-17
Alergopol283111/01/2016ene-17
Alergopol438611/01/2016ene-17
Alergopol438711/01/2016ene-17
Alergopol438811/01/2016ene-17
Alergopol438911/01/2016ene-17
Alergopol439011/01/2016ene-17
Alergopol439111/01/2016ene-17
Alergopol307318/01/2016ene-17
Alergopol407918/01/2016ene-17
Alergopol439218/01/2016ene-17
Alergopol439318/01/2016ene-17
Alergopol439418/01/2016ene-17
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Alergopol420007/11/2016nov-17
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Alergopol454328/11/2016nov-17
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Alergopol477328/11/2016nov-17

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