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 | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing Sort descending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| RH058 | Levonorgestrel Tablet 1.5mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet | Prequalification - Abridged | |
| MA093 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 20mg/160mg | Finished Pharmaceutical Product | Malaria | Alfasigma S.p.A | Tablet, Film-coated | Prequalification - Abridged | |
| HA108 | Zidovudine Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| HA098 | Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Solution, Oral | Prequalification - Abridged | |
| TB386 | Pretomanid Tablet 200mg | Finished Pharmaceutical Product | Tuberculosis | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| HA096 | Ritonavir Solution, Oral 80mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Ltd | Solution, Oral | Prequalification - Abridged | |
| HA107 | Abacavir (sulfate) Solution, Oral 20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| HA705 | Amphotericin B Powder for concentration for dispersion for infusion 50mg | Finished Pharmaceutical Product | HIV/AIDS | Gilead Sciences Ireland UC | Powder for concentration for dispersion for infusion | Prequalification - Abridged | |
| IN006 | Oseltamivir (phosphate) Capsules, hard 75mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| HA706 | Abacavir (sulfate)/Lamivudine Tablet, Film-coated 600mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| TB336 | Rifapentine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | Tuberculosis | Sanofi | Tablet, Film-coated | Prequalification - Abridged | |
| HA128 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | Prequalification - Abridged | |
| HA106 | Abacavir (sulfate) Tablet, Film-coated 300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| NT009 | Ivermectin Tablet 3mg | Finished Pharmaceutical Product | Neglected tropical diseases | Edenbridge Pharmaceuticals LLC | Tablet | Prequalification - Abridged | |
| HA109 | Zidovudine Capsules, hard 250mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Capsules, hard | Prequalification - Abridged | |
| MA026 | Artemether/Lumefantrine Tablet 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet | Prequalification - Abridged | |
| RH049 | Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mcg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Limited | Tablet + Tablet | Prequalification - Abridged | |
| HA634 | Dolutegravir (sodium) Tablet, Film-coated 50mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| CV006 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA704 | Itraconazole Capsules, hard 100mg | Finished Pharmaceutical Product | HIV/AIDS | Laboratorios Liconsa S.A. | Capsules, hard | Prequalification - Abridged | |
| TB229 | Para-aminosalicylate (sodium) Powder for Oral solution 4g | Finished Pharmaceutical Product | Tuberculosis | OlainFarm JSC | Powder for Oral solution | Prequalification - Abridged | |
| HA640 | Rifabutin Capsules, hard 150mg | Finished Pharmaceutical Product | HIV/AIDS | Lupin Ltd. | Capsules, hard | Prequalification - Abridged | |
| MA069 | Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg | Finished Pharmaceutical Product | Malaria | Novartis Pharma AG | Tablet, Dispersible | Prequalification - Abridged | |
| BT-ON002 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Celltrion Inc. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| TB384 | Meropenem Powder for solution for injection 1g | Finished Pharmaceutical Product | Tuberculosis | Venus Pharma GmbH | Powder for solution for injection | Prequalification - Abridged | |
| TB264 | Ethambutol hydrochloride Tablet, Film-coated 400mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet, Film-coated | Prequalification - Abridged | |
| HP032 | Entecavir Tablet, Film-coated 1 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| BT-ON010 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 1.1% benzyl alcohol + 440mg | Biotherapeutic Product | Oncology | Roche Products Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| RH042 | Ethinylestradiol/Levonorgestrel Tablet, Film-coated+Placebo Tablet 0.03mg/0.15mg+0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet + Tablet, Film-coated | Prequalification - Abridged | |
| TB266 | Isoniazid Tablet 300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged | |
| IN005 | Oseltamivir (phosphate) Capsules, hard 45mg | Finished Pharmaceutical Product | Influenza | Roche Registration GmbH | Capsules, hard | Prequalification - Abridged | |
| HA428 | Efavirenz Tablet, Film-coated 200mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA491 | Ritonavir Tablet, Film-coated 100mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| HA738 | Ciprofloxacin Tablet, Film-coated 500mg | Finished Pharmaceutical Product | HIV/AIDS | Unique Pharmaceutical Laboratories (Mumbai) | Tablet, Film-coated | Prequalification - Abridged | |
| HP024 | Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg | Finished Pharmaceutical Product | Hepatitis B and C | Gilead Sciences Ireland UC | Tablet, Film-coated | Prequalification - Abridged | |
| RH041 | Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg | Finished Pharmaceutical Product | Reproductive health | Lupin Ltd. | Tablet + Tablet | Prequalification - Abridged | |
| HA115 | Zidovudine Solution, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution, Oral | Prequalification - Abridged | |
| HA110 | Lamivudine/Zidovudine Tablet, Film-coated 150mg/300mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA636 | Morphine hydrochloride Tablets, Prolonged release 10mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HA693 | Flucytosine Tablet 500mg | Finished Pharmaceutical Product | HIV/AIDS | Mylan Laboratories Limited | Tablet | Prequalification - Abridged | |
| BT-ON004 | Rituximab Concentrate for solution for infusion 100mg/10mL | Biotherapeutic Product | Oncology | Celltrion Inc. | Concentrate for solution for infusion | Prequalification - Abridged | |
| HA117 | Lamivudine Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Film-coated | Prequalification - Abridged | |
| HA600 | Etravirine Tablet 25mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen-Cilag International NV | Tablet | Prequalification - Abridged | |
| RH082 | Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Sugar coated 30mcg/150mcg + 0mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, Sugar coated + Tablet, Sugar coated | Prequalification - Abridged | |
| HA602 | Aciclovir Powder for solution for injection 250mg/vial | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Powder for solution for injection | Prequalification - Abridged | |
| TB270 | Isoniazid/Rifampicin Capsules, hard 150mg/300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Capsules, hard | Prequalification - Abridged | |
| BT-ON007 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Sandoz GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| HA637 | Morphine hydrochloride Tablets, Prolonged release 30mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged |
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