New WHO Public Assessment Reports (WHOPARs) published
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News
IMPORTANT WITHDRAWAL NOTICE - AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion for Infusion (HA705) - Minisart® Filter
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On 05 February 2021, Gilead Sciences Ltd.
Lab Leon Farma’s levonorgestrel prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Macleods’ sulfamethoxazole/trimethoprim prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Dong-A’s clofazimine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Micro Labs dolutegravir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Amgen’s trastuzumab prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Mylan’s trastuzumab prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Laurus’ daclatasvir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Nitrosamine concerns for rifapentine and rifampicin - Update and FAQs
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For an update on nitrosamine concerns for rifapentine and rifampicin, click on attached FAQ document.
First velpatasvir active pharmaceutical ingredient (API) prequalified
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Velpatasvir (WHOAPI-353) manufactured by Mylan Laboratories Ltd has been prequalified by the WHO Prequalification Unit - Medicines Team (PQT/MED) under its API prequalification procedure.
First ever vaccine listed under WHO emergency use
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On 13 November 2020, WHO listed the nOPV2 vaccine (Bio Farma, Indonesi
First dihydroartemisinin/piperaquine 30mg/240mg dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First pretomanid prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Remdesivir removed from the PQT Invitations for Expression of Interest (EOIs) (FPPs and APIs)
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Remdesivir removed from the PQT Invitations for Expression of Interest (EOIs) (FPPs and APIs).
See link for recent World Health Organization (WHO) recommendations:
New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
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New Invitation for Expression of Interest (EOI) for Active Pharmaceutical Ingredients (APIs) published
New Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
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New Invitation for Expression of Interest (EOI) to manufacturers of antimalarial medicines published
New Invitation for Expression of Interest (EOI) for HIV infection and related diseases medicines published
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New Invitation for Expression of Interest (EOI) for HIV/AIDS medicines published
Draft TSS 7 - Annex 1: Qualification of usability for self-testing with rapid diagnostic tests to detect hepatitis C antibody - available for public comment
IVD
The DRAFT TSS 7 - Annex 1 Qualification of usability for self-testing with rapid diagnostic tests to detect hepatitis C antibody is now avaiable for public comments.
Dexamethasone injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Shanghai Desano’s dolutegravir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Nitrosamine concerns for Priftin (rifapentine) - Update
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WHO Prequalification Unit - Medicines Assessment Team (PQT/MED) has been in contact with Sanofi regarding the presence of 1-cyclopentyl-4-nitrosopiperazine (CPNP) in their tuberculosis treatment -
First paediatric lopinavir/ritonavir granules prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First ledipasvir/sofosbuvir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First generic sofosbuvir/velpatasvir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Mylan’s daclatasvir/sofosbuvir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Desogestrel/Ethinylestradiol prequalified
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WHO Prequalification Unit (PQT) added the below newproducts to its prequalified list:
Nitrosamine concerns for rifapentine and rifampicin
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Nitrosamine impurities have been identified in rifapentine and rifampicin products.
First remdesivir prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list: