FPPs/BTPs under assessment
This section of the website provides information on the status of FPP dossiers that are currently under assessment (i.e. not yet prequalified).
It includes:
- only those dossiers that have been screened and accepted for assessment.
It does not include:
- prequalified FPPs; once an FPP has been prequalified it is included in the WHO List of Prequalified Medicinal Products.
| INN, dosage form and strength | Quality Status | Efficacy Status |
|---|---|---|
| Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Dispersible 60mg/5mg/30mg |
|
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| Albendazole Tablets, Chewable 400mg |
|
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| Albendazole Tablets, Chewable 400mg |
|
|
| Albendazole Tablets, Chewable 400mg |
|
|
| Arginine/Sodium Bicarbonate Solution for injection+Artesunate Powder for solution for injection 20mg/ml/8.4mg/ml+180mg |
|
|
| Artemether/Lumefantrine Tablet 20 mg/120 mg |
|
|
| Artemether/Lumefantrine Tablet 40 mg/240 mg |
|
|
| Artemether/Lumefantrine Tablet 80 mg/480 mg |
|
|
| Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg |
|
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| Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg |
|
|
| Artesunate Powder for solution for injection + Arginine/Sodium Bicarbonate Solution for injection 30mg+20mg/ml/8.4mg/ml |
|
|
| Artesunate Powder for solution for injection + Sodium Bicarbonate Solution for injection + Sodium Chloride Solution for injection 50mg/ml + 9mg/ml+120mg |
|
|
| Artesunate Powder for solution for injection+Arginine/Sodium Bicarbonate Solvent for parenteral use 120mg/vial+20mg/ml/8.4mg/ml |
|
|
| Atazanavir (sulfate)/Ritonavir Tablet, Film-coated 300mg/100mg |
|
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| Azithromycin Tablet, Film-coated 500mg |
|
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| Bedaquiline (fumarate) Tablet 100mg |
|
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| Bedaquiline fumarate Tablet 100mg |
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| Bedaquiline fumarate Tablet 100mg |
|
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| Bedaquiline fumarate Tablet 100mg |
|
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| Darunavir/Ritonavir Tablet, Film-coated 400mg/50mg |
|
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| Darunavir/Ritonavir Tablet, Film-coated 800mg/100mg |
|
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| Dolutegravir (sodium) Tablet, Dispersible 10mg |
|
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| Dolutegravir (sodium) Tablet, Dispersible 10mg |
|
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| Dolutegravir (sodium) Tablet, Dispersible 5mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg |
|
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| Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg |
|
|
| Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg |
|
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| Entecavir Tablet, Film-coated 0.5mg |
|
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| Entecavir Tablet, Film-coated 1mg |
|
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| Ethambutol hydrochloride Tablet, Dispersible 100mg |
|
|
| Ethambutol hydrochloride Tablet, Dispersible 100mg |
|
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| Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg |
|
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| Ethinylestradiol/Levonorgestrel Tablet, Film-coated 30μg/150μg |
|
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| Isoniazid Tablet, Dispersible 100mg |
|
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| Isoniazid Tablet, Dispersible 100mg |
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| Isoniazid/Pyrazinamide/Rifampicin Tablet, Dispersible 50mg/150mg/75mg |
|
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| Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg |
|
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| Linezolid Tablet, Dispersible 150mg |
|
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| Miltefosine Capsules, hard 50 mg |
|
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| Molnupiravir Capsules, hard 200 mg |
|
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| Molnupiravir Capsules, hard 200mg |
|
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| Molnupiravir Capsules, hard 200mg |
|
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| Molnupiravir Capsules, hard 200mg |
|
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| Molnupiravir Capsules, hard 200mg |
|
|
| Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg |
|
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| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
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| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
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| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
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| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
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| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
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| Norethisterone Tablet 0.35mg |
|
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| Pretomanid Tablet 200 mg |
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| Pretomanid Tablet 200mg |
|
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| Primaquine Tablet, Film-coated 15mg |
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| Pyrimethamine/Sulfadoxine Tablet 25 mg/500 mg |
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| Pyrimethamine/Sulfadoxine Tablet 25mg/500mg |
|
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| Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg+76.5mg |
|
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| Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg+153mg |
|
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| Remdesivir Powder for solution for injection 100mg |
|
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| Rifapentine Tablet, Dispersible 150mg |
|
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| Rifapentine Tablet, Film-coated 300 |
|
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| Ritonavir Tablet, Film-coated 100mg |
|
|
| Sodium Stibogluconate Solution for injection 100mg/ml |
|
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| Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg |
|
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| Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg |
|
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| Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg |
|
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| Tenofovir disoproxil fumarate Tablet, Film-coated 300mg |
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|
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