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Prequalification Update - 30 August 2007

 

WHO Prequalification Programme adds 5 new HIV/AIDS products to its list of prequalified medicines

The 5 new products added to the list of prequalified HIV/AIDS products are as follows:

  • Lamivudine/Stavudine     150mg/30mg   Tablets   Cipla Ltd    HDPE bottle  60

  • Lamivudine/Stavudine     150mg/40mg   Tablets   Cipla Ltd    HDPE bottle  60

  • Lamivudine/Stavudine + Efavirenz    150mg/30mg + 600mg   Tablets  Ranbaxy Laboratories Ltd  Alu/Alu blister 2 + 1;  Cardboard box  30 + 15

  • Lamivudine/Stavudine + Efavirenz    150mg/40mg + 600mg   Tablets  Ranbaxy Laboratories Ltd  Alu/Alu blister 2 + 1;  Cardboard box  30 + 15

  • Lamivudine/Zidovudine + Efavirenz  150mg/300mg + 600mg  Tablets  Ranbaxy Laboratories Ltd  Alu/Alu blister 2 + 1; Cardboard box 30 + 15

 

Related Link:   57th Edition List of HIV/AIDS Prequalified Products and Manufacturers

 

WHO Prequalification Programme adds 3 new malaria products to its list of prequalified medicines

The 3 new products added to the list of prequalified malaria products are as follows:

  • Amodiaquine     150mg    Film-coated tablets     Guilin Pharmaceutical Co., Ltd    PVC/Alu blisters 6;  Cardboard box 2 x 6

  • Artesunate  + Amodiaquine    50mg + 150mg   tablets  Guilin Pharmaceutical Co., Ltd  PVC blisters sealed with an aluminium foil lid 4 + 4; Cardboard box 3 x (4 + 4)

  • Artesunate    50mg     Tablets     Ipca Laboratories Ltd     PVdC/Alu  12

The SPC (Summary of Product Characteristics) for amodiaquine 150mg film-coated tablets is published on the WHOPAR page. The corresponding Patient Information Leaflet (PIL) is under development.

The SPC for artesunate + amodiaquine 50mg + 150mg co-blistered tablets including a restricted therapeutic indication, as well as the corresponding PIL are under development.

 

Related Link:   6th Edition List of Malaria Prequalified Products and Manufacturers