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
- 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.
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WHO Reference Number Sort descending | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing | Date of Prequalification |
---|---|---|---|---|---|---|---|
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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