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
"*" refers to products approved by both WHO Prequalification Programme and US FDA
USFDA1 approved by US FDA; USFDA2 tentatively approved by US FDA; EMEA Art 58 - approved by EMEA according to Article 58
Note: For information about the listing of prequalified products and the alternative approval procedure, please see: General information
| Therapeutic area | INN | Formulation and strength | Applicant | Manufacturing site | Packaging | Reference no. | Date of PQ | Status |
|---|---|---|---|---|---|---|---|---|
| RH | Ethinylestradiol + Desogestrel | Tablets 0.030mg + 0.150mg | NV Organon | Kloosterstraat, Oss, The Netherlands | PVC/Alu blister further packed in an Aluminium bag 21 + 7 (placebo) | RH025 | 29-Sep-2010 | |
| RH | Ethinylestradiol + Levonorgestrel | Tablets 30µg + 150µg | Famy Care Ltd | Valsad, Gujarat, India | PVC/PVdC/Alu blister 1x21, 3x21, 6x21, 13x21, 100x21 | RH013 | 29-Sep-2011 | |
| RH | Ethinylestradiol + Levonorgestrel | Tablets 30µg + 150µg | Cipla Ltd | Goa, India | Al/PVC/PVDC/PE strip 21 + 7 (placebo) per strip, (1 or 3 strips in a carton) | RH030 | 22-Dec-2011 | |
| RH | Ethinylestradiol + Levonorgestrel | Coated tablets 30µg + 150µg | Bayer Pharma AG | Bayer Weimar GmbH and Co. KG, Germany | PVC/Alu blister 3 x (21 + 7) (verum tablets + placebos) | RH003 | 26-May-2009 | |
| RH | Etonogestrel | Implants 68mg | NV Organon | Kloosterstraat, Oss, The Netherlands | Blister pack (polyethyleneterephtalate glycol sealed with coated paper) 1 implant (in the cannula of a disposable sterile applicator) | RH020 | 02-Jun-2010 | |
| RH | Etonogestrel | Implant (X-ray detectable) 68mg | NV Organon | Kloosterstraat, Oss, The Netherlands | Blister pack (PETG sealed with HDPE lidding); 1 implant (preloaded in the stainless steel needle of a ready-to-use, disposable, sterile applicator) | RH036 | 23-May-2013 | |
| RH | Levonorgestrel | Tablets 0.75mg | Gedeon Richter Plc | Budapest, Hungary | Al/PVC blister 1 x 2 | RH024 | 20-Aug-2010 | |
| RH | Levonorgestrel | Implants (without inserter) 2 rods each with 75mg | Bayer Oy | Turku, Finland | PE bag (manufactured from spunbonded PE film and a PET/PE film), 2 rods in one package | RH017 | 23-Sep-2009 | |
| RH | Levonorgestrel | Coated tablets 30µg | Bayer Pharma AG | Bayer Weimar GmbH and Co. KG, Germany | PVC/Alu blister 3 x 35 | RH002 | 26-May-2009 | |
| RH | Lynestrenol | Tablets 500µg | NV Organon | Kloosterstraat, Oss, The Netherlands | PVC/Alu strip 1 x 28, 3 x 28 | RH021 | 02-Jun-2010 | |
| RH | Medroxyprogesterone acetate | Suspension for injection 150mg/ml | Pfizer | Rijksweg, Puurs, Belgium | Glass vial 1ml | RH018 | 20-Aug-2010 | |
| RH | Norethisterone enantate | Injection 200mg/ml | Bayer Schering Pharma AG | Berlin, Germany | Glass ampoule 1ml (100 per carton) | RH022 | 05-Oct-2011 |