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| BLOOD PRODUCTS OF HUMAN ORIGIN AND PLASMA SUBSTITUTES / PRODUCTOS DE SANGRE DE ORIGEN HUMANO Y SUSTITUTOS DE PLASMA |
| Plasma-derived medicines / Medicamentos derivados del plasma |
| International Nonproprietary Name (INN) / Denominacion Comun Internacional (DCI) |
Strength / Concentracion |
Dosage form / Forma farmaceutica |
Packing / Envase |
Packing size / Tamano del envase |
Packaging type / Tipo de empaque |
Prequalified by WHO / Precalificado por OMS |
Link to prequalification list / Enlace a la lista de precalificacion |
Approved by EMA or other agencies / Aprobado por EMA o por otras agencias (1) |
Approved by FDA or tentatively approved by FDA / Aprobado o tentativamente aprobado por FDA (1) |
Indication (s) / Indicacion (es) |
Notes / Notas |
Reference price / Precio de referencia (2) |
Purchase documents / Documentos para compra |
| Human normal immunoglobulin |
16% protein solution / Solucion proteica al 16% |
Injection for intramuscular administration / Inyeccion para administracion intramuscular |
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Plasma fractions for specific use / Fracciones de plasma para uso especifico |
Indicated for primary immune deficiency. / Indicado para deficiencia inmune primaria. |
Upon request /
A peticion |
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| Human normal immunoglobulin |
5% protein solution / Solucion proteica al 5% |
Injection for intravenous administration / Inyeccion para administracion intravenosa |
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Plasma fractions for specific use / Fracciones de plasma para uso especifico |
Indicated for primary immune deficiency and Kawasaki disease. / Indicado para deficiencia inmune primaria y enfermedad de Kawasaki. |
Upon request /
A peticion |
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| Human normal immunoglobulin |
10% protein solution / Solucion proteica al 10% |
Injection for intravenous administration / Inyeccion para administracion intravenosa |
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Plasma fractions for specific use / Fracciones de plasma para uso especifico |
Indicated for primary immune deficiency and Kawasaki disease. / Indicado para deficiencia inmune primaria y enfermedad de Kawasaki. |
Upon request /
A peticion |
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| Coagulation factor VIII |
500 UI/vial |
Powder for injection / Polvo para inyeccion |
Vial / Vial |
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Blood coagulation factors / Factores de coagulacion de la sangre |
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Upon request /
A peticion |
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| Coagulation factor IX |
500 UI/vial |
Powder for injection / Polvo para inyeccion |
Vial / Vial |
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Blood coagulation factors / Factores de coagulacion de la sangre |
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Upon request /
A peticion |
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| Coagulation factor IX |
1000 UI/vial |
Powder for injection / Polvo para inyeccion |
Vial / Vial |
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Blood coagulation factors / Factores de coagulacion de la sangre |
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Upon request /
A peticion |
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| anti-D immunoglobulin (human) |
250 mcg in single-dose vial / 250 mcg en vial de dosis unica |
Injection / Inyeccion |
Vial / Vial |
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Prevention of newborn hemolytic illnesses;
Rh negative populations (prophylaxis) / Prevencion de enfermedades hemoliticas en recien nacidos; Poblaciones Rh negativas (profilaxis) |
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Upon request /
A peticion |
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| (1) Link to list of approved products is https://extranet.who.int/prequal/content/prequalified-lists/medicines. El Enlace a la lista de productos aprobados es https://extranet.who.int/prequal/content/prequalified-lists/medicines |
| (2) The price stated in the link (if available) is to be used as reference, since such price could be variable among different suppliers. El precio indicado en el enlace (si esta disponible) se utiliza como referencia, ya que dicho precio podria ser varia |
