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Codes ATC: L01FA01
Indication
Chronic lymphocytic leukaemia or small lymphocytic lymphoma Code ICD11: 2B52.0
INN
Rituximab
Type de médicament
Biological agent
Type de liste
Liste complémentaire
Additional notes
Including quality-assured biosimilars
Formulations
Parenteral > General injections > IV: 100 mg per 10 mL in 10 mL vial ; 500 mg per 50 mL in 50 mL vial
Historique des statuts LME
Ajouté pour la première fois en 2015 (TRS 994)
Modifié en 2019 (TRS 1021)
Sexe
Tous
Âge
Adolescents et adultes
Équivalence thérapeutique
La recommandation concerne ce médicament spécifique
Renseignements sur le brevet
Main patents have expired but secondary patents might remain active in some jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Lire la suite sur les brevets.
Balises
Wikipédia
DrugBank
Résumé des preuves et recommandation du comité d'experts
The Committee noted the correspondence from the European Society for Medical Oncology (ESMO) requesting recognition of biosimilars of rituximab and trastuzumab on the EML. The Committee agreed that quality-assured biosimilars of these monoclonal antibodies represent an opportunity for expanding affordable access to cancer medicines for health systems. To help improve access, the Committee recommended the current listing for intravenous rituximab on the EML should indicate that quality-assured biosimilars of rituximab should also be considered as essential medicines. In addition, the Expert Committee recommended that WHO continue to facilitate access to biosimilars through the Prequalification programme and WHO Collaborative Registration Procedure.