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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
TB384 Meropenem Powder for solution for injection 1g Finished Pharmaceutical Product Tuberculosis Venus Pharma GmbH Powder for solution for injection Prequalification - Abridged
TB385 Cycloserine Capsules, hard 250mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Capsules, hard Prequalification - Full
TB386 Pretomanid Tablet 200mg Finished Pharmaceutical Product Tuberculosis Mylan Laboratories Limited Tablet Prequalification - Abridged
TB388 Delamanid Tablet, Film-coated 50mg Finished Pharmaceutical Product Tuberculosis Mylan Laboratories Limited Tablet, Film-coated Prequalification - Full
TB389 Linezolid Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Micro Labs Limited Tablet, Dispersible Prequalification - Full
TB391 Linezolid Tablet, Dispersible 150mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Dispersible Prequalification - Full
TB392 Isoniazid Tablet 300mg Finished Pharmaceutical Product Tuberculosis Svizera Labs Pvt. Ltd. Tablet Prequalification - Full
TB393 Rifapentine Tablet, Film-coated 300mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet, Film-coated Prequalification - Full
TB396 Bedaquiline fumarate Tablet 100mg Finished Pharmaceutical Product Tuberculosis Lupin Ltd. Tablet Prequalification - Full
TB398 Rifapentine Tablet, Film-coated 300 mg Finished Pharmaceutical Product Tuberculosis Macleods Pharmaceuticals Ltd Tablet, Film-coated Prequalification - Full
TB401 Pyridoxine hydrochloride Tablet, Film-coated 50mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet, Film-coated Prequalification - Full
TB405 Isoniazid Tablet, Dispersible 100mg Finished Pharmaceutical Product Tuberculosis S Kant Healthcare Ltd Tablet, Dispersible Prequalification - Full
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
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