Medicines/Finished Pharmaceutical Products

E.g., 10/17/2017
E.g., 10/17/2017
Formulation:
Legend:
  • "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
  • [A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
  • (a) means SRA-approved innovator or SRA-approved generic that has been prequalified based on abbreviated assessment
  • "*" refers to products approved by both WHO and US FDA
  • USFDA1 approved by US FDA
  • USFDA2 tentatively approved by US FDA
  • EMA Art. 58 - approved by EMA according to Article 58

  • Note:
  • For information about the listing of prequalified products and the alternative approval procedure, please see: General Information
  • Click on the WHO REFERENCE NUMBER to see more detailed information

  • Displaying: 1 - 50 of 512
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    DI002 Zinc (sulfate) Diarrhoea Nutriset, BP 35, le Bois Ricard, Malaunay, 76770, France Tablet, Dispersible 20mg 04 Dec 2012
    DI004 Zinc (as sulfate) Diarrhoea Alkem Laboratories Ltd, Alkem House, "Devashish" Senapati Bapat Marg, Lower Parel, Mumbai, 400 013, India Tablet, Dispersible 20mg 19 Feb 2014
    DI005 Zinc sulfate Diarrhoea Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Anheri-Kurla Road, Andheri (E), Mumbai, 400 059, India Tablet, Dispersible 20mg 07 Dec 2016
    EMA Art 58 H-C-002652 Misoprostol Reproductive Health Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland Tablet 200mcg
    EMA Art 58 H-W-2319 Artesunate/Pyronaridine (phosphate) Malaria Shin Poong Pharmaceutical Co Ltd, 748-31 Yoksam-Dong, Gangnam-Gu, Seoul, 135-925, Republic of Korea Tablet, Film-coated 60mg/180mg
    EMA Art 58 H-W-2319-3 Artesunate/Pyronaridine (phosphate) Malaria Shin Poong Pharmaceutical Co Ltd, 748-31 Yoksam-Dong, Gangnam-Gu, Seoul, 135-925, Republic of Korea Granules for Oral suspension 20mg/60mg
    EMA Art 58 H-W-764-1 Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, Abbott House, Vanwall Road, Maidenhead, SL6 4XE, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 200mg/50mg
    EMA Art 58 H-W-764-2 Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, Abbott House, Vanwall Road, Maidenhead, SL6 4XE, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 100mg/25mg
    HA034 (a) Sulfadiazine HIV/AIDS Doms Recordati, Parc Mecatronic, Saint Victor, 3410, France Tablet 500mg 20 Mar 2002
    HA039 * Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mg 20 Mar 2002
    HA051 * Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 300mg 20 Mar 2002
    HA052 * Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 100mg 20 Mar 2002
    HA053 * Lamivudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Solution, Oral 50mg/5mL 20 Mar 2002
    HA054 * Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Solution, Oral 50mg/5mL 20 Mar 2002
    HA056 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 100mg 20 Mar 2002
    HA057 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 250mg 20 Mar 2002
    HA058 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 500mg 20 Mar 2002
    HA059 Ciprofloxacin (hydrochloride) HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 750mg 20 Mar 2002
    HA060 * Lamivudine/Zidovudine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 150mg/300mg 30 Nov 2004
    HA096 (a) Ritonavir HIV/AIDS Abbott Laboratories Ltd, Abbott House, Norden Road, Maidenhead, Berkshire, SL6 4XE, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL 20 Mar 2002
    HA098 (a) Lopinavir/Ritonavir HIV/AIDS AbbVie Ltd, Abbott House, Vanwall Road, Maidenhead, SL6 4XE, United Kingdom of Great Britain and Northern Ireland Solution, Oral 80mg/mL/20mg/mL 20 Mar 2002
    HA106 (a) Abacavir (sulfate) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 300mg 20 Mar 2002
    HA107 (a) Abacavir (sulfate) HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 20mg/mL 20 Mar 2002
    HA108 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 100mg 29 May 2002
    HA109 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Capsules, hard 250mg 29 May 2002
    HA110 (a) Lamivudine/Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 150mg/300mg 20 Mar 2002
    HA114 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution for injection 10mg/mL 20 Mar 2002
    HA115 (a) Zidovudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 50mg/5mL 20 Mar 2002
    HA117 (a) Lamivudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 150mg 20 Mar 2002
    HA128 (a) Lamivudine HIV/AIDS ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Solution, Oral 10mg/mL 20 Mar 2002
    HA130 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Syrup 40mg/mL/8mg/mL 28 Feb 2003
    HA131 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet, Film-coated 800mg/160mg 29 May 2002
    HA132 (a) Sulfamethoxazole/Trimethoprim HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet 400mg/80mg 16 Dec 2002
    HA133 (a) Saquinavir (mesylate) HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Capsules, soft 200mg 20 Mar 2002
    HA134 (a) Gancyclovir (sodium) HIV/AIDS Roche, Basel, Switzerland Powder for solution for injection 500mg 29 May 2002
    HA137 (a) Ceftriaxone HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Ceftriaxone 500mg + water for injection 500mg 29 May 2002
    HA138 (a) Ceftriaxone HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Ceftriaxone 250mg + lidocaine solvent 250mg 29 May 2002
    HA141 (a) Zalcitabine HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet, Film-coated 0.375mg 20 Mar 2002
    HA142 (a) Zalcitabine HIV/AIDS F Hoffmann - La Roche Ltd, Basel, Switzerland Tablet, Film-coated 0.75mg 20 Mar 2002
    HA153 * Lamivudine HIV/AIDS Hetero Labs Ltd, Unit 3, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Qutubullapur, Rangareddy District, Andhra Pradesh, 500 055, India Tablet, Film-coated 150mg 29 May 2007
    HA155 * Nevirapine HIV/AIDS Hetero Labs Ltd, 7-2-A-2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Rangareddy District, Telangana, 500 012, India Tablet 200mg 04 Jul 2003
    HA200 Nevirapine HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Suspension, Oral 50mg/5mL 25 May 2009
    HA208 Fluconazole HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 150mg 13 Jul 2004
    HA209 Fluconazole HIV/AIDS Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 200mg 13 Jul 2004
    HA268 * Nevirapine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet 200mg 01 Apr 2005
    HA275 Lamivudine/Nevirapine/Zidovudine HIV/AIDS Hetero Labs Ltd, Unit 3, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Qutubullapur, Rangareddy District, Andhra Pradesh, 500 055, India Tablet, Film-coated 150mg/200mg/300mg 23 May 2006
    HA282 Lamivudine HIV/AIDS Aspen Pharmacare Ltd., PO Box 1587, Gallo Manor 2052, Woodlands Drive, Building 12, Healthcare Park, Woodmead, Johannesburg, Gauteng, 2191, South Africa Tablet, Film-coated 150mg 01 Dec 2005
    HA286 Lamivudine/Zidovudine HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet, Film-coated 150mg/300mg 11 Aug 2005
    HA291 * Lamivudine/Zidovudine HIV/AIDS Strides Shasun Ltd, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Anekal Taluk, Bangalore, Karnataka, 560 076, India Tablet, Film-coated 150mg/300mg 30 Jun 2006
    HA298 * Nevirapine HIV/AIDS Sun Pharmaceutical Industries Limited, Unit 1 & 2, Ganguwala Village, Paonta Sahib, Sirmour District, Himanchal Pradesh, 173 025, India Tablet 200mg 29 Sep 2005
    CSVMedicines/Finished Pharmaceutical Products