New WHO Public Assessment Reports (WHOPARs) published
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News
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
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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:
Sandoz’ rituximab prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
First clofazimine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First ivermectin prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Guilin’s DHA/piperaquine 60/480 mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
CALL FOR NOMINATIONS: Roster of Experts for Assessment of Covid-19 Vaccines
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CLOSING DATE: 30 September 2020
WHO will commence the screening of submissions and assessment of Covid-19 vaccine candidates.
Newly prequalified Quality Control Laboratories (QCLs)
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New addition to the List of Prequalified Quality Control
Bayer’s estradiol/norethisterone injection in pre-filled syringes prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Sun’s dolutegravir 50mg tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
UPDATE - Question & Answer - COVID-19 and WHO PQT Inspections
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First published on 05 May 2020 - Q&A document updated
First estradiol/norethisterone injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First invitation of dexamethasone and remdesivir for Covid-19 published
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The 1st Invitation to Manufacturers of therapeutics against COVID-19 to submit an Expression of Interest (EOI) for Product Evaluation was published today by the Prequalification Unit (PQT)
20th Invitation to Manufacturers of Antituberculosis Medicines to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit (PQT)
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Changes to the 20th TB EOI
Nitrosamine concerns in Priftin (Rifapentine)
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WHO Prequalification Unit - Medicines Assessment Team (PQ
Q&A: Dexamethasone and COVID-19
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The World Health Organization (WHO) has welcomed the init
WHO Public Assessment Report (WHOPAR) for trastuzumab published
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The below WHO Public Assessment Report (WHOPAR) for trastuzumab was published:
FAQ for variations updated
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The WHO Prequalification Unit (PQT) updated the FAQ varia
First rituximab similar biotherapeutic products prequalified
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On 25 May 2020 the World Health Organization (WHO) prequa