FPPs 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.
Assessment in progress
Additional data to be provided by the manufacturer
Dossier part acceptable
Product (INNs) Strength Dosage Form Quality Status Efficacy Status
Abacavir (sulfate)/Lamivudine 120mg/60mg Tablet, Dispersible
Green
Green
Abacavir (sulfate)/Lamivudine 120mg/60mg Tablet, Dispersible
Red
Green
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Green
Green
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Red
Green
Albendazole 400mg Tablets, Chewable
Red
Yellow
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Yellow
Green
Arginine/Sodium Bicarbonate + Artesunate 20mg/ml/8.4mg/ml + 60mg Powder for solution for injection
Yellow
Red
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Green
Artemether/Lumefantrine 20mg/120mg Tablet
Red
Green
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Green
Artemether/Lumefantrine 80mg/480mg Tablet
Red
Green
Artemether/Lumefantrine 80mg/480mg Tablet
Yellow
Green
Artesunate + Sodium Bicarbonate + Sodium Chloride 60mg/vial + 50mg/ml + 9mg/ml Powder for solution for injection
Green
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Red
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Red
Green
Carbetocin 100 mcg/ml Solution for injection
Yellow
Yellow
Cycloserine 250mg Capsules, hard
Yellow
Green
Darunavir 400mg Tablet, Film-coated
Yellow
Green
Darunavir 600mg Tablet, Film-coated
Yellow
Green
Darunavir 800mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate)/Ritonavir 400mg/50mg Tablet, Film-coated
Red
Green
Darunavir/Ritonavir 400mg/50mg Tablet, Film-coated
Red
Green
Darunavir/Ritonavir 800mg/100mg Tablet, Film-coated
Red
Green
Delamanid 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 10mg Tablet, Dispersible
Red
Red
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Green
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Red
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil fumarate 50mg/300mg/300mg Tablet, Film-coated
Red
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Red
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Red
Yellow
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Red
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Red
Yellow
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Red
Green
Ethambutol hydrochloride 100mg Tablet, Dispersible
Yellow
Green
Ethambutol hydrochloride 50mg Tablet, Dispersible
Yellow
Green
Ethinylestradiol/Levonorgestrel 30mcg/150mcg Tablet, Sugar coated
Red
Green
Ethinylestradiol/Levonorgestrel 30mcg/150mcg Tablet, Film-coated
Yellow
Yellow
Ethinylestradiol/Levonorgestrel + Ferrous Fumarate 0.03mg/0.15mg + 75mg Tablet, Film-coated
Red
Green
Flucytosine 250mg Tablet
Yellow
Green
Flucytosine 500mg Tablet
Yellow
Green
Isoniazid 300mg Tablet
Red
Green
Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim 300mg/25mg/800mg/160mg Tablet, Film-coated
Yellow
Green
Isoniazid/Rifampicin 50mg/75mg Tablet, Dispersible
Yellow
Green
Isoniazid/Rifapentine 300mg/300mg Tablet, Film-coated
Red
Green
Ivermectin 3mg Tablet
Yellow
Green
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Red
Green
Levofloxacin 250mg Tablet, Film-coated
Green
Green
Levofloxacin 250mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Lopinavir/Ritonavir 100mg/25mg Tablet, Film-coated
Red
Red
Lopinavir/Ritonavir 200mg/50mg Tablet, Film-coated
Red
Yellow
Magnesium sulfate 50%w/v Solution for injection
Yellow
Green
Medroxyprogesterone acetate 150mg/ml Suspension for injection
Red
Yellow
Misoprostol 200mcg Tablet
Red
Yellow
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Norethisterone 0.35mg Tablet
Yellow
Green
Praziquantel 600mg Tablet, Film-coated
Yellow
Yellow
Praziquantel 600mg Tablet, Film-coated
Green
Green
Primaquine 15mg Tablet, Film-coated
Red
Green
Primaquine 3.75mg Tablet, Film-coated
Red
Green
Primaquine 5mg Tablet, Film-coated
Red
Green
Primaquine 7.5mg Tablet, Film-coated
Red
Green
Protionamide 250mg Tablet, Film-coated
Green
Green
Pyridoxine hydrochloride 10mg Tablet
Yellow
Green
Pyridoxine hydrochloride 50mg Tablet
Yellow
Green
Pyrimethamine/Sulfadoxine 12.50mg/250mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 12.5mg/250mg Tablet, Dispersible
Red
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Red
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.50mg/250mg + 76.5mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 75mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 25mg/500mg + 150mg Tablet, Dispersible
Red
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 25mg/500mg + 153mg Tablet, Dispersible
Yellow
Green
Remdesivir (suspended) 100mg Powder for solution for injection
Yellow
Green
Remdesivir (suspended) 100mg/vial Powder for solution for injection
Yellow
Yellow
Ritonavir 25mg Tablet, Film-coated
Yellow
Yellow
Sofosbuvir/Velpatasvir 400mg/100mg Tablet, Film-coated
Yellow
Yellow
Zinc (sulfate) 10mg/5ml Syrup
Green
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Green
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Yellow
Green