Medicines

The International Pharmacopoeia (Ph. Int.): Medicines for HIV/AIDS (ARVs)

Proposals for inclusion

It is proposed to include monographs for the following substances and dosage forms. Letters are being sent to known manufacturers of these items inviting them to co-operate in the development of these monographs for publication. Any manufacturers not directly contacted are hereby invited to submit proposals for appropriate specifications and analytical procedures. For further information, please contact: E-mail: qsm@who.int

APIs

  • Atazanavir

Dosage forms

  • Atazanavir capsules
  • Emtricitabine oral liquid
  • Ritonavir oral solution
  • Stavudine oral solution
  • Zidovudine tablets

Fixed-dose combinations (FDC)

  • Lamivudine + Stavudine tablets
  • Lamivudine + Stavudine + Nevirapine tablets
  • Lopinavir + Ritonavir capsules
  • Lopinavir + Ritonavir oral solution
  • Lopinavir + Ritonavir tablets

International Chemical Reference Substances (ICRS)

The International Chemical Reference Substances (ICRS) required to support the monograph specifications in The International Pharmacopoeia are established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations by the WHO Collaborating Centre for Chemical Reference Substances. Information about the ICRS is available from the centre.

Monographs in preparation

Collaborative work is currently being carried out on the development of monographs for the following substances and dosage forms. Draft specifications are circulating for public comment.

  • Didanosine capsules
  • Tenofovir and emtricitabine tablets
  • Tenofovir and emtricitabine and efavirenz tablets
Adopted monographs

The monographs listed here have been adopted by the Expert Committee on Specifications for Pharmaceutical Preparations.

Share