Martindale December 2023 Update | Pharmaceutical Press

This update contains 8 new monographs, and 7 existing monographs have been updated. Preparations have been updated for 5 countries.

New Monographs

Bimekizumab is a humanised monoclonal antibody that binds to and blocks proinflammatory cytokines involved in skin inflammation. It is used for the treatment of moderate to severe plaque psoriasis.
Eflapegrastim is a granulocyte colony-stimulating factor that stimulates the development of granulocytes. It is given to prevent neutropenia as an adjunct in cancer chemotherapy.
Inebilizumab is a CD19-directed recombinant humanised monoclonal antibody used in the treatment of neuromyelitis optica spectrum disorder.
Lenacapavir is an HIV-1 capsid inhibitor used with other antiretrovirals for the treatment of multidrug-resistant HIV-1 infection and AIDS in treatment-experienced patients.
Olipudase alfa is an exogenous source of the enzyme, acid sphingomyelinase. It is used for the treatment of non-CNS manifestations of acid sphingomyelinase deficiency (Niemann-Pick disease type A/B, or type B).
Satralizumab, a recombinant humanised monoclonal antibody that targets the interleukin-6 receptor, is used in the treatment of neuromyelitis optica spectrum disorder.
Ublituximab is a recombinant anti-CD20 monoclonal antibody that is used for the treatment of relapsing forms of multiple sclerosis.
Volanesorsen, an antisense oligonucleotide, is used for genetically-confirmed familial chylomicronemia syndrome with a high risk of pancreatitis, in patients who have had an inadequate response to diet and triglyceride lowering therapy.

New salts or related derivatives added to existing monographs

Selective Updates – some new, re-validated or changed information

Monographs

Updated names, synonyms and codes; official standards; official preparations:

Proprietary Preparations and Manufacturers updated for the following countries and regions:

† Countries updated on an ongoing basis