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.
Displaying: 101 - 150 of 667
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| WHO Reference Number | INN, Dosage Form and Strength | Product Type | Therapeutic Area | Applicant | Dosage Form Sort descending | Basis of Listing | Date of Prequalification |
|---|---|---|---|---|---|---|---|
| RH018 | Medroxyprogesterone acetate Powder for suspension for injection 150mg/mL | Finished Pharmaceutical Product | Reproductive health | Pfizer AB | Powder for suspension for injection | Prequalification - Abridged | |
| RH104 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 2,400,000IU + 6 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| RH103 | Benzathine benzylpenicillin Powder for suspension for injection + Water for Injection Solvent for parenteral use 1,200,000IU + 4 mL | Finished Pharmaceutical Product | Reproductive health | LABORATORIO REIG JOFRE, S.A. | Powder for suspension for injection + Solvent for parenteral use | Prequalification - Abridged | |
| IN007 | Zanamivir Powder, for Inhalation 5mg | Finished Pharmaceutical Product | Influenza | Glaxo Wellcome UK Ltd | Powder, for Inhalation | Prequalification - Abridged | |
| BT-EB002 | Atoltivimab/Maftivimab/Odesivimab Solution for infusion 33.33mg/mL/33.33mg/mL/33.33mg/mL | Biotherapeutic Product | Ebola Virus Disease | Regeneron Pharmaceuticals Inc. | Solution for infusion | Prequalification - Abridged | |
| BT-EB001 | Atoltivimab/Maftivimab/Odesivimab Solution for Infusion 16.67 mg/mL/16.67 mg/mL/16.67 mg/mL | Biotherapeutic Product | Ebola | Regeneron Pharmaceuticals Inc. | Solution for Infusion | Prequalification - Abridged | |
| HA734 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Farmak JSC | Solution for injection | Prequalification - Full | |
| HA607 | Ondansetron (hydrochloride) Solution for injection 8mg/4mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| RH072 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Labesfal, Laboratorios Almiro SA | Solution for injection | Prequalification - Abridged | |
| RH064 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| BT-DM005 | Insulin Glargine Solution for injection 100 U/mL | Biotherapeutic Product | Diabetes | Sanofi-Aventis Deutschland GmbH | Solution for injection | Prequalification - Abridged | |
| BT-DM001 | Insulin Human Solution for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Solution for injection | Prequalification - Abridged | |
| RH022 | Norethisterone enantate Solution for injection 200mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer plc | Solution for injection | Prequalification - Abridged | |
| HA114 | Zidovudine Solution for injection 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution for injection | Prequalification - Abridged | |
| TB328 | Kanamycin (sulfate) - non sterile Solution for injection 1000mg/3ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| RH050 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | PT Sanbe Farma | Solution for injection | Prequalification - Full | |
| CV004 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml | Finished Pharmaceutical Product | Covid-19 | Farmak JSC | Solution for injection | Prequalification - Full | |
| RH083 | Oxytocin Solution for injection 10IU/mL | Finished Pharmaceutical Product | Reproductive health | Steril-Gene Life Sciences (P) Ltd | Solution for injection | Prequalification - Full | |
| TB317 | Kanamycin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Shanghai Harvest Pharmaceutical Co., Ltd | Solution for injection | Prequalification - Full | |
| RH063 | Magnesium sulphate Solution for injection 500mg/ml (2ml) | Finished Pharmaceutical Product | Reproductive health | AS KALCEKS | Solution for injection | Prequalification - Full | |
| RH062 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Inresa Arzneimittel GmbH | Solution for injection | Prequalification - Abridged | |
| CV006 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (2ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| RH086 | Magnesium sulphate Solution for injection 500mg/ml (10ml) | Finished Pharmaceutical Product | Reproductive health | Joint-Stock Company Halychpharm | Solution for injection | Prequalification - Full | |
| RH073 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| RH095 | Carbetocin Solution for injection 100 mcg/ml | Finished Pharmaceutical Product | Reproductive health | Ferring International Center SA | Solution for injection | Prequalification - Full | |
| BT-DM006 | Insulin Glargine Solution for injection 100 U/mL | Biotherapeutic Product | Diabetes | Sanofi-Aventis Deutschland GmbH | Solution for injection | Prequalification - Abridged | |
| RH079 | Oxytocin Solution for injection 10IU/ml | Finished Pharmaceutical Product | Reproductive health | JSC Grindeks | Solution for injection | Prequalification - Full | |
| TB327 | Kanamycin (sulfate) Solution for injection 500mg/2ml | Finished Pharmaceutical Product | Tuberculosis | Livzon (Group) Pharmaceutical Factory | Solution for injection | Prequalification - Full | |
| RH087 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/ml/50mg/ml | Finished Pharmaceutical Product | Reproductive health | Bayer S.A. | Solution for injection | Prequalification - Full | |
| RH054 | Estradiol valerate/Norethisterone enantate Solution for injection 5mg/50mg/mL | Finished Pharmaceutical Product | Reproductive health | Bayer AG | Solution for injection | Prequalification - Full | |
| BT-DM002 | Insulin Human Solution for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Solution for injection | Prequalification - Abridged | |
| CV005 | Dexamethasone (sodium phosphate) Solution for injection 4mg/ml (1ml) | Finished Pharmaceutical Product | Covid-19 | Demo SA | Solution for injection | Prequalification - Abridged | |
| RH077 | Magnesium sulphate Solution for injection 500mg/mL | Finished Pharmaceutical Product | Reproductive health | Aurum Pharmaceuticals Ltd | Solution for injection | Prequalification - Abridged | |
| HA597 | Ondansetron (hydrochloride) Solution for injection 4mg/2mL | Finished Pharmaceutical Product | HIV/AIDS | Demo SA | Solution for injection | Prequalification - Abridged | |
| TB319 | Amikacin (sulfate) Solution for injection 500mg | Finished Pharmaceutical Product | Tuberculosis | Qilu Pharmaceutical Co.,Ltd | Solution for injection | Prequalification - Full | |
| ANDA 091475 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Alternative Listing | |
| HA523 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| ANDA 077695 USFDA | Lamivudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA107 | Abacavir (sulfate) Solution, Oral 20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| HA128 | Lamivudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare BV | Solution, Oral | Prequalification - Abridged | |
| ANDA 077268 USFDA | Zidovudine Solution, Oral 10mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA096 | Ritonavir Solution, Oral 80mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Ltd | Solution, Oral | Prequalification - Abridged | |
| HA098 | Lopinavir/Ritonavir Solution, Oral 80mg/mL/20mg/mL | Finished Pharmaceutical Product | HIV/AIDS | AbbVie Deutschland GmbH and Co. KG | Solution, Oral | Prequalification - Abridged | |
| HA115 | Zidovudine Solution, Oral 50mg/5mL | Finished Pharmaceutical Product | HIV/AIDS | ViiV Healthcare UK Limited | Solution, Oral | Prequalification - Abridged | |
| HA526 | Zidovudine Solution, Oral 10mg/mL | Finished Pharmaceutical Product | HIV/AIDS | Macleods Pharmaceuticals Ltd | Solution, Oral | Prequalification - Full | |
| ANDA 077950 USFDA | Abacavir (sulfate) Solution, Oral 20mg/ml | Finished Pharmaceutical Product | HIV/AIDS | Aurobindo Pharma Ltd | Solution, Oral | Alternative Listing | |
| HA486 | Zidovudine Solution, Oral 10mg | Finished Pharmaceutical Product | HIV/AIDS | Hetero Labs Ltd | Solution, Oral | Prequalification - Full | |
| BT-ON014 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 20mL + 420mg | Biotherapeutic Product | Oncology | Biocon Biologics Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Full | |
| BT-ON010 | Water for Injection Solvent for parenteral use + Trastuzumab Powder for concentrate for solution for infusion 1.1% benzyl alcohol + 440mg | Biotherapeutic Product | Oncology | Roche Products Limited | Solvent for parenteral use + Powder for concentrate for solution for infusion | Prequalification - Abridged | |
| BT-DM003 | Insulin Human Suspension for injection 100IU/ml | Biotherapeutic Product | Diabetes | Novo Nordisk AS | Suspension for injection | Prequalification - Abridged |
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