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.
First ever vaccine listed under WHO emergency use
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On 13 November 2020, WHO listed the nOPV2 vaccine (Bio Farma, Indonesia) for eme
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 -
Nitrosamine concerns for rifapentine and rifampicin
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Nitrosamine impurities have been identified in rifapentine and rifampicin products.
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)
First rituximab similar biotherapeutic products prequalified
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WHO Prequalification Unit (PQT) added the below new products to its prequalified list:
WHO Prequalification Unit – Medicines request to manufacturers to conduct risk assessments to evaluate the potential for the presence of nitrosamine impurities
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Background
Medicine Regulatory Authorities firs
First meropenem prequalified
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WHO Prequalification Unit (PQT) added the below new product to its prequalified list:
First biosimilar product prequalified
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WHO Prequalification Team - Medicines (PQTm) added the below new product to its prequalified list:
Nitrosamine contamination – Recent international alerts
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The WHO Prequalification Team (PQT) is aware, and monitoring closely, announcements by major regulators regarding the presence of nitrosamine impurities in batches of sartan-related products, piog