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) Dosage form & strength Dosage Form Quality Status Efficacy Status
Abacavir (sulfate)/Lamivudine 600mg/300mg Tablet, Film-coated
Red
Green
Albendazole 400mg Tablets, Chewable
Yellow
Green
Albendazole 400mg Tablets, Chewable
Red
Yellow
Albendazole 400mg Tablets, Chewable
Yellow
Green
Arginine/Sodium Bicarbonate + Artesunate 20mg/ml/8.4mg/ml + 60mg Powder for solution for injection
Yellow
Red
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Red
Green
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Red
Artemether/Lumefantrine 40mg/240mg Tablet
Yellow
Yellow
Artemether/Lumefantrine 80mg/480mg Tablet
Yellow
Green
Atazanavir (sulfate)/Ritonavir 150mg/50mg Tablet, Film-coated
Yellow
Yellow
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate)/Ritonavir 300mg/100mg Tablet, Film-coated
Green
Green
Bedaquiline (fumarate) 100mg Tablet
Yellow
Green
Bedaquiline (fumarate) 100mg Tablet
Red
Green
Bedaquiline (fumarate) 100mg Tablet
Red
Yellow
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Yellow
Yellow
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Yellow
Yellow
Darunavir/Ritonavir 400mg/50mg Tablet, Film-coated
Yellow
Green
Darunavir/Ritonavir 800mg/100mg Tablet, Film-coated
Yellow
Green
Delamanid 50mg Tablet, Film-coated
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 40mg/320mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Green
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
Green
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 400mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Green
Green
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate 600mg/300mg/300mg Tablet, Film-coated
Green
Green
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin 275mg/75mg/400mg/150mg Tablet, Film-coated
Yellow
Green
Ethinylestradiol/Levonorgestrel 30mcg/150mcg Tablet, Sugar coated
Yellow
Green
Ethinylestradiol/Levonorgestrel 30mcg/150mcg Tablet, Film-coated
Green
Green
Fluconazole 2mg/mL Solution for injection
Yellow
Yellow
Flucytosine 500mg Tablet
Red
Green
Isoniazid 300mg Tablet
Yellow
Green
Isoniazid 300mg Tablet
Red
Green
Isoniazid/Pyridoxine hydrochloride/Sulfamethoxazole/Trimethoprim 300mg/25mg/800mg/160mg Tablet, Film-coated
Green
Green
Isoniazid/Rifapentine 300mg/300mg Tablet, Film-coated
Yellow
Green
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Yellow
Green
Linezolid 150mg Tablet, Dispersible
Yellow
Green
Linezolid 150mg Tablet, Dispersible
Yellow
Green
Lopinavir/Ritonavir 100mg/25mg Tablet, Film-coated
Yellow
Yellow
Lopinavir/Ritonavir 200mg/50mg Tablet, Film-coated
Yellow
Green
Magnesium sulfate 50%w/v Solution for injection
Green
Green
Misoprostol 200mcg Tablet
Red
Green
Molnupiravir 200mg Capsules, hard
Yellow
Green
Molnupiravir 200mg Capsules, hard
Red
Red
Molnupiravir 200mg Capsules, hard
Red
Green
Norethisterone 0.35mg Tablet
Yellow
Green
Praziquantel 600mg Tablet, Film-coated
Red
Green
Praziquantel 600mg Tablet, Film-coated
Green
Green
Pretomanid 200mg Tablet
Red
Green
Primaquine 15mg Tablet, Film-coated
Red
Green
Pyrimethamine/Sulfadoxine 12.50mg/250mg Tablet, Dispersible
Red
Yellow
Pyrimethamine/Sulfadoxine 12.50mg/250mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet
Yellow
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Yellow
Green
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet, Dispersible
Yellow
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
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 25mg/500mg + 153mg Tablet, Dispersible
Yellow
Green
Remdesivir 100mg Powder for solution for injection
Yellow
Green
Remdesivir (suspended) 100mg/vial Powder for solution for injection
Yellow
Yellow
Rifapentine 300mg Tablet, Film-coated
Yellow
Green
Rifapentine 300mg Tablet, Film-coated
Red
Green
Sofosbuvir/Velpatasvir 400mg/100mg Tablet, Film-coated
Yellow
Green
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Yellow
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Yellow
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Yellow
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Yellow
Tenofovir disoproxil fumarate 300mg Tablet, Film-coated
Yellow
Green
Zinc (sulfate) 10mg/5ml Syrup
Green
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Yellow
Red
Zinc (sulfate) 20mg Tablet, Dispersible
Green
Green