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Medicines (Finished Pharmaceutical Products/Biotherapeutic products) - Prequalification

  • "+" means co-packaged product while “/” means fixed dose combination
  • [A/B] + C means A and B are in a fixed-dose formulation and C is co-packaged
Note:
  • For information about the listing of prequalified products and the alternative listing procedure, please see: General Information
  • Some products prequalified via abridged assessment may have different storage conditions and shelf life from those accepted by the reference authority. For more information, see WHOPAR part 1.
  • In product details page, the FPP sites that are used only for primary packaging are listed under “FPP Packaging only” section.
Displaying: 651 - 667 of 667
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WHO Reference Number INN, Dosage Form and Strength Product Type Therapeutic Area Applicant Dosage Form Basis of Listing Date of Prequalification
BT-DM005 Insulin Glargine Solution for injection 100 U/mL Biotherapeutic Product Diabetes Sanofi-Aventis Deutschland GmbH Solution for injection Prequalification - Abridged
BT-EB001 Atoltivimab/Maftivimab/Odesivimab Solution for Infusion 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL Biotherapeutic Product Ebola Regeneron Pharmaceuticals Inc. Solution for Infusion Prequalification - Abridged
BT-EB002 Atoltivimab/Maftivimab/Odesivimab Solution for infusion 33.33mg/mL/33.33mg/mL/33.33mg/mL Biotherapeutic Product Ebola Virus Disease Regeneron Pharmaceuticals Inc. Solution for infusion Prequalification - Abridged
HA789 Cabotegravir Suspension for injection 600mg/3mL Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare Pty Ltd Suspension for injection Prequalification - Abridged
HA788 Cabotegravir (sodium) Tablet, Film-coated 30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare Pty Ltd Tablet, Film-coated Prequalification - Abridged
MR001 Cefiderocol Powder for concentrate for solution for infusion 1g/vial Finished Pharmaceutical Product Multi-drug resistant bacterial infections Shionogi B.V. Powder for concentrate for solution for infusion Prequalification - Abridged
TD001 Nicotine resinate (polacrilex) 20% Medicated chewing gum 2mg Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Medicated chewing gum Prequalification - Abridged
TD002 Nicotine resinate (polacrilex) 20% Medicated chewing gum 4mg Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Medicated chewing gum Prequalification - Abridged
TD003 Nicotine Patch 10mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
TD004 Nicotine Patch 15mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
TD005 Nicotine Patch 25mg/16 hours Finished Pharmaceutical Product Disorders caused by tobacco use McNeil Sweden AB Patch Prequalification - Abridged
NT019 Azithromycin Tablet, Film-coated 500mg Finished Pharmaceutical Product Neglected tropical diseases ACI HealthCare Limited Tablet, Film-coated Prequalification - Abridged
HA791 Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg Finished Pharmaceutical Product HIV/AIDS ViiV Healthcare BV Tablet, Dispersible Prequalification - Abridged
EMEA/H/W/004252/001 Arpraziquantel Tablet, Dispersible 150mg Finished Pharmaceutical Product Neglected tropical diseases Merck Europe B.V. Tablet, Dispersible
NDA 215448 USFDA Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
ANDA 216875 USFDA Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
ANDA 210642 USFDA Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg Finished Pharmaceutical Product HIV/AIDS Aurobindo Pharma Ltd Tablet, Film-coated
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