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Information for professionals for Ogivri 150 mg®/Ogivri 440 mg®:Medius AG
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L01XC03 - TrastuzumabATC-DDD Version 2016. Source: WHO
L - Antineoplastic and Immunomodulating Agents

This 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.

L01X - Other Antineoplastic Agents

This group comprises antineoplastic preparations which cannot be classified in the preceding groups.
There are two groups for "Other antineoplastic agents" in this 3rd level, where L01XU Other antineoplastic agents (cont.) is a continuation of the ATC 4th level L01XX Other antineoplastic agents; these two groups should be considered as one and the same.

L01XC - Monoclonal Antibodies

Monoclonal antibodies mainly indicated for the treatment of cancer are classified in L01XC.
Dinutuximab and dinutuximab beta are classified at the same 5th level.

L01XC03 - Trastuzumab
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