Medicines/Finished Pharmaceutical Products

E.g., 11/19/2018
E.g., 11/19/2018
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 - 44 of 44
    WHO Reference Number International nonproprietary name (INN) Therapeutic Area Applicant Dosage form & strength Date of prequalification
    RH002 (a) Levonorgestrel Reproductive Health Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany Tablet, coated 30mcg 26 May 2009
    RH013 Ethinylestradiol/Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg 29 Sep 2011
    RH017 (a) Levonorgestrel Reproductive Health Bayer Pharma AG, Müllerstraße 178, Berlin, 13353, Germany Rod 75mg 23 Sep 2009
    RH018 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Manufacturing Belgium NV / SA, Rijksweg 12, Puurs 2870, Belgium Suspension for injection 150mg/mL 20 Aug 2010
    RH021 (a) Lynestrenol Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Tablet 500mcg 02 Jun 2010
    RH022 (a) Norethisterone enantate Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany Solution for injection 200mg/ml 05 Oct 2011
    RH025 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 0.150mg/0.030mg + 0mg 29 Sep 2010
    RH028 Levonorgestrel Reproductive Health Shanghai Dahua Pharmaceutical Co Ltd, 3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai, China (People's Republic of) Implant 75mg per rod (150mg in total) 30 Jun 2017
    RH030 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.150mg + 0mg 22 Dec 2012
    RH031 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 1.5mg 21 Oct 2013
    RH032 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet 750mcg 14 Jun 2013
    RH035 Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Tablet, Sugar coated 30mcg/150mcg + 0mg 21 Oct 2013
    RH036 (a) Etonogestrel Reproductive Health N V Organon, Oss, 5349 AB, Netherlands Implant 68mg 23 May 2013
    RH037 (a) Desogestrel/Ethinylestradiol Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet 0.150mg/0.030mg 14 Aug 2013
    RH038 Ethinylestradiol/Levonorgestrel + Ferrous Fumarate Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India Ethinylestradiol/Levonorgestrel Tablet + Placebo (Ferrous Fumarate Tablet) 30mcg/150mcg + 75mg 11 Mar 2014
    RH039 Misoprostol Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 200mcg 08 Apr 2014
    RH040 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 750mcg 08 Apr 2014
    RH041 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH042 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Ethinylestradiol/Levonorgestrel Tablets + Placebo Tablets 0.03mg/0.15mg + 0mg 26 Aug 2013
    RH043 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 26 Aug 2013
    RH044 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mg 21 Oct 2013
    RH045 (a) Norethisterone Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 350mcg 21 Oct 2013
    RH046 Levonorgestrel Reproductive Health Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India Tablet 1.5mg 09 Jul 2015
    RH048 Misoprostol Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mcg 22 Nov 2016
    RH049 (a) Desogestrel/Ethinylestradiol + Placebo Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mcg 08 Apr 2014
    RH050 Oxytocin Reproductive Health PT Sanbe Farma, Jl. Taman Sari No 10, Bandung, 40116, Indonesia Solution for injection 10IU/mL 30 Jun 2017
    RH051 (a) Mifepristone Reproductive Health Linepharma International, Regents Place, 338 Euston Road, London, NW1 3BT, United Kingdom of Great Britain and Northern Ireland Tablet 200mg 06 Oct 2014
    RH052 Mifepristone Reproductive Health China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of) Tablet 200mg 15 Aug 2016
    RH053 (a) Oxytocin Reproductive Health Grindeks JSC, 53 Krustpils Street, Riga, 1057, Latvia Solution for injection 10iu/mL 16 Apr 2015
    RH056 Misoprostol Reproductive Health Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India Tablet 200mcg 27 Apr 2016
    RH057 Levonorgestrel Reproductive Health Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India Tablet, Film-coated 0.03mg 15 Aug 2016
    RH058 (a) Levonorgestrel Reproductive Health Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India Tablet 1.5mg 16 Dec 2015
    RH061 (a) Mifepristone Reproductive Health Exelgyn, 216 BOULEVARD SAINT GERMAIN, Paris, 75007, France Tablet 200mg 23 May 2016
    RH062 (a) Magnesium sulphate Reproductive Health Inresa Arzneimittel GmbH, Obere Hardtstraße 18, 79114, Freiburg, Germany Solution for injection 50% 15 Aug 2016
    RH063 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (2ml) 04 Jul 2017
    RH064 Magnesium sulfate Reproductive Health AS KALCEKS, Krustpils iela 53, Rīga, LV-1057, Latvia Solution for injection 500mg/ml (10ml) 04 Jul 2017
    RH065 Levonorgestrel Reproductive Health HLL Lifecare Limited, Unipill Block, Kanagala, Belgaum, Karnataka, 591225, India Tablet 1.5mg 23 Apr 2018
    RH072 (a) Magnesium sulphate Reproductive Health Labesfal, Laboratorios Almiro SA, Unit 2, Zona Industrial do Lagedo, Santiago de Besteiros, 3465-157, Portugal Solution for injection 500mg/ml (10ml) 19 Jun 2018
    RH073 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 2ml 12 Dec 2017
    RH074 Medroxyprogesterone acetate Reproductive Health Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India Suspension for injection 150mg 31 Oct 2018
    RH075 (a) Medroxyprogesterone acetate Reproductive Health Pfizer Limited, Ramsgate Rd., Sandwich, Kent, CT13 9NJ, United Kingdom of Great Britain and Northern Ireland Suspension for injection 104mg/0.65ml 28 Nov 2017
    RH077 (a) Magnesium sulfate Reproductive Health Aurum Pharmaceuticals Ltd , Bampton Road, Harold Hill, Romford, Essex, RM3 8UG, United Kingdom Solution for injection 50% w/v, 10mL 12 Dec 2017
    RH080 (a) Ethinylestradiol/Levonorgestrel Reproductive Health Temmler Pharma GmbH, Temmlerstraße 2, 35039, Marburg, Germany Tablet, Sugar coated 30mcg/150mcg 12 Dec 2017
    RH082 (a) Ethinylestradiol/Levonorgestrel + Placebo Reproductive Health Bayer AG, Müllerstraße 178, Berlin, 13353, Germany (MAH: Jenapharm GmbH & Co. KG, Otto-Schott-Str. 15, 07745, Jena, Germany) Tablet, Sugar coated 30mcg/150mcg + 0mcg 24 Oct 2017
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