Medicines (Finished Pharmaceutical Products/Biotherapeutic products) - Prequalification
- "+" means co-packaged product while “/” means fixed dose combination
- [A/B] + C means A and B are in a fixed-dose formulation and C is co-packaged
- For information about the listing of prequalified products and the alternative listing procedure, please see: General Information
- Some products prequalified via abridged assessment may have different storage conditions and shelf life from those accepted by the reference authority. For more information, see WHOPAR part 1.
- In product details page, the FPP sites that are used only for primary packaging are listed under “FPP Packaging only” section.
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form | Basis of Listing Sort descending | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| EMEA/H/W/004252/001 | Arpraziquantel Tablet, Dispersible 150mg | Finished Pharmaceutical Product | Neglected tropical diseases | Merck Europe B.V. | Tablet, Dispersible | ||
| RH021 | Lynestrenol Tablet 500mcg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet | Prequalification - Abridged | |
| RH061 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Exelgyn | Tablet | Prequalification - Abridged | |
| TB269 | Rifampicin Capsules, hard 300mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Capsules, hard | Prequalification - Abridged | |
| RH002 | Levonorgestrel Tablet, coated 30mcg | Finished Pharmaceutical Product | Reproductive health | Jenapharm GmbH & Co. KG | Tablet, coated | Prequalification - Abridged | |
| TB346 | Terizidone Capsules, hard 250mg | Finished Pharmaceutical Product | Tuberculosis | Esteve Pharmaceuticals GmbH | Capsules, hard | Prequalification - Abridged | |
| RH037 | Desogestrel/Ethinylestradiol Tablet 0.150mg/0.030mg | Finished Pharmaceutical Product | Reproductive health | Mylan Laboratories Ltd | Tablet | Prequalification - Abridged | |
| BT-ON001 | Trastuzumab Powder for concentrate for solution for infusion 150 mg | Biotherapeutic Product | Oncology | Samsung Bioepis NL B.V. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| HA645 | Dapsone Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Everest Life Sciences LLC | Tablet | Prequalification - Abridged | |
| BT-ON005 | Rituximab Concentrate for solution for infusion 500mg/50mL | Biotherapeutic Product | Oncology | Celltrion Inc. | Concentrate for solution for infusion | Prequalification - Abridged | |
| RH022 | Norethisterone enantate Solution for injection 200mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Solution for injection | Prequalification - Abridged | |
| RH018 | Medroxyprogesterone acetate Powder for suspension for injection 150mg/mL | Finished Pharmaceutical Product | Reproductive health | Pfizer AB | Powder for suspension for injection | Prequalification - Abridged | |
| RH025 | Desogestrel/Ethinylestradiol Tablet + Placebo Tablet, coated 0.150mg/0.030mg + 0mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Tablet + Tablet, coated | Prequalification - Abridged | |
| HA768 | Dolutegravir (sodium) Tablet, Dispersible 5mg | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Tablet, Dispersible | Prequalification - Abridged | |
| HA747 | Sulfamethoxazole/Trimethoprim Tablet 400mg/80mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| TB085 | Isoniazid/Rifampicin Tablet, coated 75mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, coated | Prequalification - Abridged | |
| BT-ON008 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| BT-ON003 | Trastuzumab Powder for concentrate for solution for infusion 420mg | Biotherapeutic Product | Oncology | Celltrion Inc. | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| RH062 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Inresa Arzneimittel GmbH | Solution for injection | Prequalification - Abridged | |
| HA748 | Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg | Finished Pharmaceutical Product | HIV/AIDS | Eumedica Pharmaceuticals AG | Tablet | Prequalification - Abridged | |
| BT-ON009 | Trastuzumab Powder for concentrate for solution for infusion 150mg | Biotherapeutic Product | Oncology | Roche Products Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| CV005 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (1ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| HA532 | Etravirine Tablet 100mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet | Prequalification - Abridged | |
| MA094 | Dihydroartemisinin/Piperaquine phosphate Tablet, Film-coated 40mg/320mg | Finished Pharmaceutical Product | Malaria | Alfasigma S.p.A | Tablet, Film-coated | Prequalification - Abridged | |
| HA733 | Darunavir Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Krka, d.d., Novo mesto | Tablet, Film-coated | Prequalification - Abridged | |
| RH017 | Levonorgestrel Implant 75mg | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Implant | Prequalification - Abridged | |
| HA638 | Morphine hydrochloride Tablets, Prolonged release 60mg | Finished Pharmaceutical Product | HIV/AIDS | GL Pharma GmbH | Tablets, Prolonged release | Prequalification - Abridged | |
| HP032 | Entecavir Tablet, Film-coated 1 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| CV007 | Nirmatrelvir Tablet, Film-coated + Ritonavir Tablet, Film-coated 150mg + 100mg | Finished Pharmaceutical Product | Covid-19 | Pfizer Limited | Tablet, Film-coated + Tablet, Film-coated | Prequalification - Abridged | |
| BT-CV003 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 400 mg of tocilizumab in 20 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-CV001 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 80 mg of tocilizumab in 4 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| BT-CV002 | Tocilizumab Concentrate for solution for infusion 20mg/ml (Each vial contains 200 mg of tocilizumab in 10 mL) | Biotherapeutic Product | Covid-19 | Roche Registration GmbH | Concentrate for solution for infusion | Prequalification - Abridged | |
| HA530 | Darunavir (ethanolate) Tablet, Film-coated 150mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| TB090 | Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg | Finished Pharmaceutical Product | Tuberculosis | Sandoz Pvt Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| HA529 | Darunavir (ethanolate) Tablet, Film-coated 75mg | Finished Pharmaceutical Product | HIV/AIDS | Janssen Research & Development LLC | Tablet, Film-coated | Prequalification - Abridged | |
| HA381 | Lopinavir/Ritonavir Tablet, Film-coated 200mg/50mg | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Tablet, Film-coated | Prequalification - Abridged | |
| RH073 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| TB267 | Pyrazinamide Tablet 500mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Tablet | Prequalification - Abridged | |
| TB268 | Rifampicin Capsules, hard 150mg | Finished Pharmaceutical Product | Tuberculosis | Antibiotice SA | Capsules, hard | Prequalification - Abridged | |
| HP031 | Entecavir Tablet, Film-coated 0.5 mg | Finished Pharmaceutical Product | Hepatitis B and C | BrightGene Bio-Medical Technology Co., Ltd | Tablet, Film-coated | Prequalification - Abridged | |
| RH075 | Medroxyprogesterone acetate Suspension for injection 104mg/0.65ml | Finished Pharmaceutical Product | Reproductive health | Pfizer Limited | Suspension for injection | Prequalification - Abridged | |
| TB345 | Protionamide Tablet, Film-coated 250mg | Finished Pharmaceutical Product | Tuberculosis | Esteve Pharmaceuticals GmbH | Tablet, Film-coated | Prequalification - Abridged | |
| HA337 | Efavirenz Tablet, Film-coated 600mg | Finished Pharmaceutical Product | HIV/AIDS | Merck Sharp & Dohme BV | Tablet, Film-coated | Prequalification - Abridged | |
| RH051 | Mifepristone Tablet 200mg | Finished Pharmaceutical Product | Reproductive health | Linepharma International Ltd | Tablet | Prequalification - Abridged | |
| RH036 | Etonogestrel Implant 68mg | Finished Pharmaceutical Product | Reproductive health | NV Organon | Implant | Prequalification - Abridged | |
| BT-ON011 | Rituximab Concentrate for solution for infusion 100mg/10ml | Biotherapeutic Product | Oncology | Roche Products Limited | Concentrate for solution for infusion | Prequalification - Abridged | |
| NT001 | Diethylcarbamazine (citrate) Tablet 100mg | Finished Pharmaceutical Product | Neglected tropical diseases | Sanofi | Tablet | Prequalification - Abridged | |
| BT-ON016 | Trastuzumab Powder for concentrate for solution for infusion 420mg | Biotherapeutic Product | Oncology | Biosimilar Collaborations Ireland Limited | Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| HA716 | Ciprofloxacin Tablet, Film-coated 250mg | Finished Pharmaceutical Product | HIV/AIDS | Unique Pharmaceutical Laboratories (Mumbai) | Tablet, Film-coated | Prequalification - Abridged | |
| HA597 | Ondansetron (hydrochloride) Solution for injection 4mg/2mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged |
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