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
  • several FPPs with the same international proprietary name (INN), strength, unit and dosage form, that have are produced and have been submitted for evaluation by different manufacturers.

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
Yellow
Amikacin (sulfate) 1000mg/4ml Solution for injection
Yellow
Red
Amikacin (sulfate) 500mg Solution for injection
Yellow
Green
Amikacin (sulfate) 500mg/2ml Solution for injection
Yellow
Red
Amodiaquine (hydrochloride)/Amodiaquine (hydrochloride) + Pyrimethamine/Sulfadoxine 200mg/153mg + 25mg/500mg Co-Pack
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 135mg/50mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 135mg/50mg Tablet
Yellow
Yellow
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 270mg/100mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Yellow
Green
Amodiaquine (hydrochloride)/Artesunate 67.5mg/25mg Tablet
Yellow
Green
Artemether 80mg Solution for injection
Yellow
Red
Artemether 80mg/ml Solution for injection
Yellow
Green
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet
Yellow
Green
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Yellow
Artemether/Lumefantrine 20mg/120mg Tablet, Dispersible
Yellow
Green
Artemether/Lumefantrine 80mg/480mg Tablet
Yellow
Green
Artesunate 100mg Capsule, Soft, Rectal
Yellow
Green
Artesunate 100mg Capsule, Soft, Rectal
Yellow
Green
Artesunate + Sodium Bicarbonate + Sodium Chloride 60mg + 5%w/v + 0.9%w/v Powder and solvent for solution for injection
Yellow
Green
Artesunate/Mefloquine (hydrochloride) 100mg/200mg Tablet, Film-coated
Yellow
Green
Artesunate/Mefloquine (hydrochloride) 25mg/50mg Tablet, Film-coated
Yellow
Green
Atazanavir (sulfate) 300mg Capsules, hard
Yellow
Red
Capreomycin (sulfate) 500mg Powder for solution for injection
Yellow
Green
Ceftriaxone (sodium) 1g Powder for solution for injection
Yellow
Green
Cycloserine 125mg Capsules, hard
Yellow
Green
Cycloserine 250mg Capsules, hard
Yellow
Green
Cycloserine 250mg Capsules, hard
Yellow
Yellow
Daclatasvir (dihydrochloride) 30mg Tablet, Film-coated
Red
Red
Daclatasvir (dihydrochloride) 60mg Tablet, Film-coated
Red
Red
Darunavir 800mg Tablet, Film-coated
Green
Green
Darunavir (ethanolate) 600mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate) 800mg Tablet, Film-coated
Yellow
Green
Darunavir (ethanolate)/Ritonavir 400mg/50mg Tablet, Film-coated
Red
Red
Desogestrel/Ethinylestradiol 0.15mg/0.03mg Tablet, Film-coated
Yellow
Green
Desogestrel/Ethinylestradiol + Placebo 0.15mg/0.03mg + 0mg Tablet, Film-coated
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 20mg/160mg Tablet, Dispersible
Yellow
Yellow
Dihydroartemisinin/Piperaquine (phosphate) 40mg/320mg Tablet, Dispersible
Yellow
Yellow
Dihydroartemisinin/Piperaquine (phosphate) 40mg/320mg Tablet, Film-coated
Yellow
Green
Dihydroartemisinin/Piperaquine (phosphate) 80mg/640mg Tablet, Film-coated
Red
Yellow
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Yellow
Green
Dolutegravir (Sodium) 50mg Tablet, Film-coated
Red
Red
Dolutegravir (Sodium)/Lamivudine/Tenofovir disoproxil (fumarate) 50mg/300mg/300mg Tablet, Film-coated
Yellow
Green
Efavirenz 600mg Tablet, Film-coated
Yellow
Green
Efavirenz/Lamivudine/Tenofovir disoproxil (fumarate) 600mg/300mg/300mg Tablet, Film-coated
Green
Green
Estradiol valerate/Norethisterone enantate 5mg/50mg/mL Solution for injection
Yellow
Green
Estradiol valerate/Norethisterone enantate 5mg/ml/50mg/ml Solution for injection
Yellow
Red
Ethambutol (hydrochloride) 100mg Tablet, Dispersible
Yellow
Green
Ethambutol (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Ethinylestradiol/Levonorgestrel 0.03mg/0.15mg Tablet, Film-coated
Yellow
Yellow
Ethinylestradiol/Levonorgestrel + Placebo 0.03mg/0.15mg + 0mg Co-Pack
Yellow
Yellow
Ethionamide 125mg Tablet, Dispersible
Yellow
Green
Flucytosine 500mg Tablet
Yellow
Green
Isoniazid 100mg Tablet, Dispersible
Yellow
Green
Isoniazid 50mg Tablet, Dispersible
Yellow
Green
Isoniazid/Pyrazinamide/Rifampicin 50mg/150mg/75mg Tablet, Dispersible
Yellow
Green
Isoniazid/Rifampicin 150mg/300mg Tablet, Film-coated
Yellow
Green
Isoniazid/Rifampicin 50mg/75mg Tablet, Dispersible
Yellow
Green
Isoniazid/Rifampicin 75mg/150mg Tablet, Film-coated
Yellow
Green
Kanamycin (acid sulfate) 1g Powder for solution for injection
Green
Green
Kanamycin (acid sulfate) 500mg Powder for solution for injection
Green
Green
Kanamycin (sulfate) 1g Solution for injection
Yellow
Green
Kanamycin (sulfate) 1g/3ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 1g/3ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 500mg Solution for injection
Yellow
Green
Kanamycin (sulfate) 500mg/2ml Solution for injection
Yellow
Green
Kanamycin (sulfate) 500mg/2ml Solution for injection
Yellow
Green
Lamivudine 300mg Tablet, Film-coated
Yellow
Yellow
Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg Tablet, Film-coated
Green
Green
Lamivudine/Nevirapine/Zidovudine 150mg/200mg/300mg Tablet, Film-coated
Yellow
Yellow
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Yellow
Yellow
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Green
Green
Lamivudine/Zidovudine 150mg/300mg Tablet, Film-coated
Yellow
Green
Ledipasvir/Sofosbuvir 90mg/400mg Tablet, Film-coated
Red
Red
Levofloxacin 100mg Tablet, Dispersible
Green
Green
Levofloxacin 250mg Tablet
Yellow
Yellow
Levofloxacin 250mg Tablet, coated
Yellow
Red
Levofloxacin 250mg Tablet, Film-coated
Yellow
Green
Levofloxacin 500mg Tablet, Film-coated
Yellow
Green
Levofloxacin 750mg Tablet, Film-coated
Yellow
Green
Levonorgestrel 0.75mg Tablet
Yellow
Yellow
Levonorgestrel 1.5mg Tablet
Yellow
Green
Levonorgestrel 1.5mg Tablet
Yellow
Green
Linezolid 600mg Tablet, Film-coated
Yellow
Yellow
Linezolid 600mg Tablet, Film-coated
Yellow
Yellow
Linezolid 600mg Tablet, Film-coated
Yellow
Green
Lopinavir/Ritonavir 100mg/25mg Tablet, Film-coated
Yellow
Yellow
Magnesium sulphate 500mg/ml (10ml) Solution for injection
Yellow
Green
Medroxyprogesterone acetate 150mg Suspension for injection
Yellow
Green
Medroxyprogesterone acetate 150mg/ml Suspension for injection
Red
Yellow
Moxifloxacin (hydrochloride) 100mg Tablet, Dispersible
Yellow
Green
Moxifloxacin (hydrochloride) 100mg Tablet, Dispersible
Yellow
Green
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Green
Yellow
Moxifloxacin (hydrochloride) 400mg Tablet, Film-coated
Yellow
Green
Oxytocin 10IU/mL Solution for injection
Red
Red
Oxytocin 10IU/ml Solution for injection
Red
Green
Protionamide 250mg Tablet, Film-coated
Yellow
Green
Protionamide 250mg Tablet, Film-coated
Red
Red
Pyrimethamine/Sulfadoxine 25mg/500mg Tablet
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 75mg Co-Pack
Yellow
Green
Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride) 12.5mg/250mg + 76.5mg Co-Pack
Yellow
Green
Pyrimethamine/Sulfadoxine + Artesunate 25mg/500mg + 100mg Co-Pack
Yellow
Green
Raltegravir (potassium) 400mg Tablet, Film-coated
Yellow
Red
Rifampicin 300mg Capsules, hard
Yellow
Green
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Sofosbuvir 400mg Tablet, Film-coated
Yellow
Green
Streptomycin (sulfate) - Sterile 1000mg Powder for solution for injection
Yellow
Green
Sulfamethoxazole/Trimethoprim 400mg/80mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Sulfamethoxazole/Trimethoprim 800mg/160mg Tablet
Yellow
Green
Terizidone 250mg Capsules, hard
Yellow
Green
Valganciclovir (hydrochloride) 450mg Tablet, Film-coated
Yellow
Green
Zinc (as sulfate) 20mg Tablet, Dispersible
Yellow
Green
Zinc (sulfate) 10mg/5ml Syrup
Yellow
Green
Zinc (sulfate) 20mg Tablet, Dispersible
Yellow
Yellow