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 |
|
|
| Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg |
|
|
| Abacavir (sulfate)/Dolutegravir (sodium)/Lamivudine Tablet, Film-coated 600mg/50mg/300mg |
|
|
| Albendazole Tablet 400mg |
|
|
| Artemether/Lumefantrine Tablet 20 mg/120 mg |
|
|
| Artemether/Lumefantrine Tablet 20mg/120mg |
|
|
| Artemether/Lumefantrine Tablet 40 mg/240 mg |
|
|
| Artemether/Lumefantrine Tablet 80 mg/480 mg |
|
|
| Artemether/Lumefantrine Tablet 80mg/480mg |
|
|
| Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg |
|
|
| Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg |
|
|
| Artesunate Powder for solution for injection + Arginine/Sodium Bicarbonate Solution for injection 30mg+20mg/ml/8.4mg/ml |
|
|
| Azithromycin Tablet, Film-coated 500mg |
|
|
| Bedaquiline fumarate Tablet 100mg |
|
|
| Bedaquiline fumarate Tablet 100mg |
|
|
| Cycloserine Capsules, hard 250mg |
|
|
| Darunavir/Ritonavir Tablet, Film-coated 400mg/50mg |
|
|
| Darunavir/Ritonavir Tablet, Film-coated 800mg/100mg |
|
|
| Delamanid Tablet, Film-coated 50mg |
|
|
| Delamanid Tablet, Film-coated 50mg |
|
|
| Delamanid Tablet, Film-coated 50mg |
|
|
| Dolutegravir (sodium) Tablet, Dispersible 10mg |
|
|
| Dolutegravir (sodium) Tablet, Film-coated 50mg |
|
|
| Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg |
|
|
| Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg |
|
|
| Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg |
|
|
| Dolutegravir (sodium)/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 50mg/200mg/25mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir alafenamide Tablet, Film-coated 50mg/300mg/25mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir alafenamide Tablet, Film-coated 50mg/300mg/25mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir alafenamide Tablet, Film-coated 50mg/300mg/25mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg |
|
|
| Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg |
|
|
| Efavirenz/Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 400mg/200mg/25mg |
|
|
| Emtricitabine/Ethinylestradiol/Levonorgestrel/Tenofovir disoproxil fumarate Tablet, Film-coated + Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/0.03mg/0.15mg/300mg + 200mg/300mg |
|
|
| Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg |
|
|
| Emtricitabine/Tenofovir alafenamide Tablet, Film-coated 200mg/25mg |
|
|
| Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg |
|
|
| Ethambutol hydrochloride Tablet, Dispersible 100mg |
|
|
| Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg |
|
|
| Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Ferrous (Fumarate) Tablet, Film-coated 0.03mg/0.15mg + 75mg |
|
|
| Isoniazid Tablet, Dispersible 100mg |
|
|
| Isoniazid/Moxifloxacin (hydrochloride)/Pyrazinamide/Rifapentine Tablet, Film-coated 75mg/100mg/375mg/300mg |
|
|
| Isoniazid/Moxifloxacin (hydrochloride)/Rifapentine Tablet, Film-coated 75mg/100mg/300mg |
|
|
| Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg |
|
|
| Levonorgestrel Tablet, Film-coated 0.03mg |
|
|
| Linezolid Tablet, Dispersible 150mg |
|
|
| Linezolid Tablet, Dispersible 150mg |
|
|
| Medroxyprogesterone acetate - Sterile Suspension for injection 104mg/0.65ml |
|
|
| Miltefosine Capsules, hard 50 mg |
|
|
| Molnupiravir Capsules, hard 200mg |
|
|
| Moxifloxacin (hydrochloride) Tablet, Dispersible 100mg |
|
|
| Moxifloxacin (hydrochloride) Tablet, Film-coated 400mg |
|
|
| Mtb-specific antigen rCFP-10/Mtb-specific antigen rdESAT-6 Solution for injection 0.5 mcg per mL/0.5 mcg per mL |
|
|
| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
|
| Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg |
|
|
| Praziquantel Tablet, Film-coated 600mg |
|
|
| Pretomanid Tablet 200mg |
|
|
| Primaquine (phosphate) Tablet, Dispersible 2.5mg |
|
|
| Primaquine (phosphate) Tablet, Dispersible 2.5mg |
|
|
| Primaquine (phosphate) Tablet, Dispersible 5mg |
|
|
| Primaquine (phosphate) Tablet, Dispersible 5mg |
|
|
| Primaquine (phosphate) Tablet, Dispersible 7.5mg |
|
|
| Primaquine Tablet, Film-coated 15mg |
|
|
| Pyridoxine hydrochloride Tablet 10mg |
|
|
| Pyrimethamine/Sulfadoxine Tablet 25 mg/500 mg |
|
|
| Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 12.5mg/250mg+76.5mg |
|
|
| Pyrimethamine/Sulfadoxine Tablet, Dispersible+Amodiaquine (hydrochloride) Tablet, Dispersible 25mg/500mg+153mg |
|
|
| Remdesivir Powder for solution for injection 100mg |
|
|
| Rifapentine Tablet, Dispersible 150mg |
|
|
| Sodium Stibogluconate Solution for injection 100mg/ml |
|
|
| Sofosbuvir/Velpatasvir Tablet, Film-coated 400mg/100mg |
|
|
| Tranexamic acid Solution for injection 100mg/ml |
|
|
.