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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 - 655 of 655
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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
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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