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| ANTIVIRALS / ANTIVIRALES |
| Anti hepatitis medicines / Medicamentos contra la hepatitis |
| 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 OMS prequalification list / Enlace a la lista de precalificacion de OMS |
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 |
| Entecavir |
0.05 mg/ml |
Oral solution / Solucion oral |
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Chronic Hepatitis B / Hepatitis B cronica |
|
Upon request /
A peticion |
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| Entecavir |
0.5 mg |
Tablet / Tableta |
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Chronic Hepatitis B / Hepatitis B cronica |
|
Upon request /
A peticion |
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| Entecavir |
1 mg |
Tablet / Tableta |
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Chronic Hepatitis B / Hepatitis B cronica |
|
Upon request /
A peticion |
|
| Tenofovir disoproxil fumarate |
300 mg |
Tablet / Tableta |
Container / Recipiente |
30 tablets container / Recipiente de 30 tabletas |
HDPE Container 30x1 / Recipiente PEAD 30x1 |
Ref: HA329 (a) |
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Chronic Hepatitis B / Hepatitis B cronica |
|
http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=35058&lang=es |
|
| Tenofovir disoproxil fumarate |
300 mg |
Tablet / Tableta |
Bottle / Frasco |
30 tablets bottle / Frasco de 30 tabletas |
HDPE Bottle 30x1 / Frasco PEAD 30x1 |
Ref: HA401 *
Ref: HA410 *
Ref: HA508 *
Ref: HA516
Ref: HA535 *
Ref: HA588 |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
|
Ref: USFDA ANDA 09-0647 2
|
Chronic Hepatitis B / Hepatitis B cronica |
|
http://www.paho.org/hq/index.php?option=com_docman&task=doc_view&Itemid=270&gid=35058&lang=es |
|
| Tenofovir disoproxil fumarate |
300 mg |
Tablet / Tableta |
Bottle / Frasco |
100 tablets bottle / Frasco de 100 tabletas |
HDPE Bottle 100x1 / Frasco PEAD 100x1 |
Ref: HA410 *
|
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis B / Hepatitis B cronica |
|
Upon request /
A peticion |
|
| Tenofovir disoproxil fumarate |
300 mg |
Tablet / Tableta |
Blister / Blister |
10 tablets bottle / Blister por 10 tabletas |
Blister Alu/Alu: 10x2
Blister Alu/Alu: 10x1 |
Ref: HA410 *
Ref: HA535 *
|
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis B / Hepatitis B cronica |
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Upon request /
A peticion |
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| Daclatasvir |
30 mg |
Tablet / Tableta |
Blister / Blister |
14 tablets blister / Blister por 14 tabletas |
Blister Alu/PVC-ACLAR: 14x2 |
Ref: HP007 (a) |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis C/ Hepatitis C cronica |
|
Upon request /
A peticion |
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| Daclatasvir |
60 mg |
Tablet / Tableta |
Blister / Blister |
14 tablets blister / Blister por 14 tabletas |
Blister Alu/PVC-ACLAR: 14x2 |
Ref: HP008 (a) |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis C/ Hepatitis C cronica |
|
Upon request /
A peticion |
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| Dasabuvir |
250 mg |
Tablet / Tableta |
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Chronic Hepatitis C/ Hepatitis C cronica |
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Upon request /
A peticion |
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| Ledipasvir + Sofosbuvir |
90 mg + 400 mg |
Tablet / Tableta |
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Chronic Hepatitis C/ Hepatitis C cronica |
|
Upon request /
A peticion |
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| Ombitasvir + Paritaprevir + Ritonavir |
12.5 mg + 75 mg + 50 mg |
Tablet / Tableta |
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Chronic Hepatitis C/ Hepatitis C cronica |
|
Upon request /
A peticion |
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| Simeprevir |
150 mg |
Capsule / Capsula |
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Chronic Hepatitis C/ Hepatitis C cronica |
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Upon request /
A peticion |
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| Sofosbuvir |
400 mg |
Tablet / Tableta |
Bottle / Frasco |
28 tablets bottle / Frasco por 28 tabletas |
Bottle-white HDPE 28x1; Bottle-blue HDPE 28x1 / Frasco blanco PEAD 28x1; Frasco azul PEAD 28x1 |
Ref: HP001
Ref: HP004 |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis C/ Hepatitis C cronica |
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Upon request /
A peticion |
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| Sofosbuvir |
400 mg |
Tablet / Tableta |
Bottle / Frasco |
84 tablets bottle / Frasco por 84 tabletas |
HDPE Bottle 84x1 / Frasco PEAD 84x1 |
Ref: HP004 |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis C/ Hepatitis C cronica |
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Upon request /
A peticion |
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| Sofosbuvir |
400 mg |
Tablet / Tableta |
Blister / Blister |
14 tablets blister / Blister por 14 tabletas |
Blister Alu-PVC/PE/PVdC: 14x2 |
Ref: HP004 |
https://extranet.who.int/prequal/content/prequalified-lists/medicines |
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Chronic Hepatitis C/ Hepatitis C cronica |
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Upon request /
A peticion |
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| Sofosbuvir + Velpatasvir |
400 mg + 100 mg |
Tablet / Tableta |
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Chronic Hepatitis C/ Hepatitis C cronica |
|
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 |
