WHO Public Assessment Reports (WHOPARs) published
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News
Two PQT Medicines workshops for manufacturers: The 4th Annual Quality Workshop for Manufacturers and the 1st Biotherapeutics Workshop for Manufacturers
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For further information see: /prequal/events/two-pqt-medicines-workshops-manufacturers
ICH Harmonised Guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” implemented and updated biowaiver documentation published
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Effective 25 May 2021 the ICH guideline M9 “Biopharmaceutics Classification System-Based Biowaivers” is implemented by PQT/MED.
Tocilizumab and sarilumab invited for COVID-19
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Tocilizumab and sarilumab invited for COVID-19.
Macleods’ abacavir/lamivudine prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Medopharm’s praziquantel prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
New artesunate injection prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Guilin’s artemether/lumefantrine dispersible tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
S Kant’s SP dispersible tablet co-packed with amodiaquine dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
S Kant’s pyrimethamine/sulfadoxine dispersible tablets prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
First albendazole prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Public announcement to TB in vitro diagnostics manufacturers, procurement agencies and national TB programmes on inclusion of WHO Prequalification for TB in vitro diagnostics
IVD
The World Health Organization (WHO), through its Prequalification Unit and Global Tuberculosis Programme, would like to announce future changes to the WHO procedure to determine procurement eligibi
Macleods’ 100mg isoniazid dispersible tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First biosimilars prequalified after full assessment
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
Emcure’s dolutegravir/lamivudine/tenofovir tablet prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
Ipca’s sulfamethoxazole/trimethoprim prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
IMPORTANT WITHDRAWAL NOTICE - AmBisome Liposomal Amphotericin B 50mg Powder for Concentrate for Dispersion for Infusion (HA705) - Minisart® Filter
IS
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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.