Medicines/Finished Pharmaceutical Products

E.g., 08/19/2019
E.g., 08/19/2019
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: 251 - 300 of 545
    WHO Reference Numbersort descending International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    HA704 (a) Itraconazole HIV/AIDS Universal Farma S.L., Gran Via Carlos III, 98, 7th floor, Barcelona, 08028, Spain Capsules, hard 100mg 17 Jul 2018
    HA705 (a) Amphotericin B HIV/AIDS Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Powder for concentration for dispersion for infusion 50mg 19 Jun 2018
    HA706 (a) Abacavir (sulfate)/Lamivudine HIV/AIDS ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom of Great Britain and Northern Ireland Tablet, Film-coated 600mg/300mg 19 Jun 2018
    HA716 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 250mg 18 Dec 2018
    HA721 (a) Efavirenz/Lamivudine/Tenofovir disoproxil fumarate HIV/AIDS Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 400mg/300mg/300mg 31 Oct 2018
    HA733 (a) Darunavir HIV/AIDS Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia Tablet, Film-coated 600mg 11 Jun 2019
    HA738 (a) Ciprofloxacin (hydrochloride) HIV/AIDS Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), Mumbai, 400030, India Tablet, Film-coated 500mg 11 Jun 2019
    HCnda Lamivudine/Nevirapine/Zidovudine HIV/AIDS Apotex Pharmachem Inc, PO Box 1976, Station Main, Brantford, Ontario, N3T 5W5, Canada Tablet 150mg/200mg/300mg
    HP001 Sofosbuvir Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 400mg 20 Jul 2017
    HP002 Sofosbuvir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 400mg 07 Feb 2018
    HP003 Sofosbuvir Hepatitis European Egyptian Pharmaceuticals Industries Co, PO Box 111, El Manshia Alex, Cairo Desert Road KM 25, Amriya, Alexandria, Egypt Tablet, Film-coated 400mg 18 Dec 2018
    HP004 Sofosbuvir Hepatitis Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet, Film-coated 400mg 05 Sep 2017
    HP005 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 0.5mg 28 Nov 2017
    HP006 (a) Entecavir Hepatitis Hetero Labs Ltd, 7-2-A2 Hetero Corporate Industrial Estates, Sanathnagar, Hyderabad, Telangana, 500 018, India Tablet, Film-coated 1mg 28 Nov 2017
    HP007 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 30mg 14 Oct 2016
    HP008 (a) Daclatasvir (dihydrochloride) Hepatitis Bristol-Myers Squibb Company, P.O. Box 5400, New Jersey, United States of America Tablet, Film-coated 60mg 14 Oct 2016
    HP015 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 30mg 15 May 2019
    HP016 Daclatasvir (dihydrochloride) Hepatitis Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Film-coated 60mg 15 May 2019
    HP024 (a) Sofosbuvir/Velpatasvir Hepatitis Gilead Sciences Ireland UC, IDA Business & Technology Park, Carrigtohill, County Cork, Ireland Tablet, Film-coated 400mg/100mg 06 Feb 2019
    IN001 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 75mg 13 May 2009
    IN002 Oseltamivir (phosphate) Influenza Strides Pharma Science Limited, Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road, Bangalore, Karnataka, 560 076, India Capsules, hard 75mg 25 Oct 2010
    IN003 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Powder for Oral suspension 12mg/mL 21 Sep 2009
    IN004 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 30mg 21 Sep 2009
    IN005 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 45mg 21 Sep 2009
    IN006 (a) Oseltamivir (phosphate) Influenza Roche Registration GmbH, Emil-Barell-Strasse, 79639 Grenzach-Wyhlen, Germany Capsules, hard 75mg 21 Sep 2009
    IN007 (a) Zanamivir Influenza Glaxo Wellcome UK Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, United Kingdom of Great Britain and Northern Ireland Powder, for Inhalation 5mg 22 Sep 2009
    IN009 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 30mg 13 Jun 2014
    IN010 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 45mg 13 Jun 2014
    IN011 Oseltamivir (phosphate) Influenza Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Capsules, hard 75mg 13 Jun 2014
    IN012 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 30mg 10 Feb 2016
    IN013 Oseltamivir (phosphate) Influenza Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Capsules, hard 45mg 10 Feb 2016
    IN014 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 30mg 21 Dec 2016
    IN015 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 45mg 21 Dec 2016
    IN016 Oseltamivir (phosphate) Influenza Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India Capsules, hard 75mg 21 Dec 2016
    MA026 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet 20mg/120mg 26 Apr 2004
    MA044 Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Tablet 50mg 21 Dec 2005
    MA045 Amodiaquine (hydrochloride) Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablet, Film-coated 150mg 30 Aug 2007
    MA046 Amodiaquine (hydrochloride) + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Amodiaquine (Hydrochloride) Tablet + Artesunate Tablet 150mg + 50mg 30 Aug 2007
    MA051 Artesunate + Sodium Bicarbonate + Sodium Chloride Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) - (Vial + Ampoule) ; 60mg/vial + 50mg/ml + 45mg/5ml 05 Nov 2010
    MA056 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 67.5mg/25mg 14 Oct 2008
    MA057 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 135mg/50mg 14 Oct 2008
    MA058 Amodiaquine (hydrochloride)/Artesunate Malaria Sanofi, 82, avenue Raspail, 94250 - Gentilly, France Tablet 270mg/100mg 14 Oct 2008
    MA062 Artemether/Lumefantrine Malaria Ipca Laboratories Ltd, Plot No 142, Kandivli Industrial Estate, Kandivli (W), Mumbai, Maharashtra, 400 067, India Tablet 20mg/120mg 15 Dec 2009
    MA064 Artemether/Lumefantrine Malaria Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 20mg/120mg 22 May 2009
    MA066 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, Room 701, N° 780, Cailun Road, Shanghai, 201 203, China (People's Republic of) Pyrimethamine/Suphadoxine Tablet + Artesunate Tablet 25mg/500mg + 50mg 24 May 2012
    MA068 Pyrimethamine/Sulfadoxine + Artesunate Malaria Guilin Pharmaceutical Co Ltd, No 43 Qilidian Road, Guilin, Guangxi, 541 004, China (People's Republic of) Tablets + Tablets 25mg/500mg + 100mg 18 Dec 2018
    MA069 (a) Artemether/Lumefantrine Malaria Novartis Pharma AG, Lichtstrasse 35, Basel, 4002, Switzerland Tablet, Dispersible 20mg/120mg 27 Feb 2009
    MA078 Artesunate/Mefloquine (hydrochloride) Malaria Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland Tablet 25mg/50mg 12 Sep 2012
    MA079 Artesunate/Mefloquine (hydrochloride) Malaria Drugs for Neglected Diseases Initiative (DNDi), 15 Chemin Louis Dunant, Geneva, 1202, Switzerland Tablet 100mg/200mg 12 Sep 2012
    MA080 Amodiaquine (hydrochloride)/Artesunate Malaria Ipca Laboratories Ltd, 48 Kandivli Industrial Estate, Kandivli (West), Mumbai, Maharashtra, 400 067, India Tablet 67.5mg/25mg 01 Jun 2012
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