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L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTSThis group comprises preparations used in the treatment of neoplastic diseases, and immunomodulating agents.
Corticosteroids for systemic use, see H02.
L01 ANTINEOPLASTIC AGENTS
Combination products are classified in L01XY - Combinations of antineoplastic agents, except for combinations of monoclonal antibodies or antibody drug conjugates which are classified in L01FY.
Detoxifying agents used in connection with high dose treatment of antineoplastic agents are classified in V03AF (e.g. calcium folinate).
Radiopharmaceuticals used in the treatment of cancer are classified in V10X.
| For antineoplastic agents, the estimation of the DDD was primarily based on standard dosing or recommended dosing expressed per body weight. Where relevant and clinically appropriate, dosing based on body surface area (BSA) of 1.73 m2 was also taken into account. Determining a single main indication for DDD assignment can be challenging for antineoplastic agents, particularly for substances authorised for a wide range of indications and associated with multiple dosing regimens. This reflects their highly individualised use and wide dosage ranges, which may vary substantially according to the type and severity of the neoplastic disease, as well as the frequent use of concomitant or combination therapy. In such cases, the indication selected for DDD estimation was the one most closely aligned with the WHO Essential Medicines List (EML). For substances not included in the WHO EML, the selected indication was based on the most prevalent disease or, where available, on utilisation data reflecting predominant clinical use. For antineoplastic agents, drug consumption is in some countries expressed in grams. This approach has historically been applied for these agents due to the substantial variability in dosing and the resulting limitations of DDD-based measures. |
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Monoclonal antibodies mainly indicated for the treatment of cancer are classified in this group.
Monoclonal antibodies combined with hyaluronidase are classified at the same 5th level as the plain monoclonal antibody.
Bispecific antibodies with different antigen targets are classified in L01FX.
L01FA CD20 (Clusters of Differentiation 20) inhibitors
High strength products of ofatumumab used for the treatment of chronic lymphocytic leukaemia (CLL) are classified in this group, while low strength products for treatment of relapsing multiple sclerosis (RMS) are classified in L04AG.
| The DDD for obinutuzumab is based on dosing for chronic lymphocytic leukaemia (CLL) and reflects dosing in treatment cycles 2-6. |
L01FB CD22 (Clusters of Differentiation 22) inhibitors
L01FC CD38 (Clusters of Differentiation 38) inhibitors
| The DDD for daratumumab is based on subcutaneous injection. |
L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
| The DDDs in this group are based on the treatment of breast cancer. The DDD for trastuzumab is based on subcutaneous injection. |
L01FE EGFR (Epidermal Growth Factor Receptor) inhibitors
L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
| The DDD for atezolizumab is based on intravenous infusion. |
L01FG VEGF/VEGFR (Vascular Endothelial Growth Factor / -Receptor) inhibitors
Bevacizumab used in age-related macular degeneration (AMD) is classified in S01LA08.
L01FX Other monoclonal antibodies and antibody drug conjugates
Dinutuximab and dinutuximab beta are classified at the same 5th level (L01FX06).
| The DDD for ipilimumab is based on the treatment of melanoma. |
L01FY Combinations of monoclonal antibodies and antibody drug conjugates
Combinations of monoclonal antibodies with hyaluronidase are classified at the same 5th level as the combinations of monoclonal antibodies without hyaluronidase.
Last updated: 2026-01-13