Directriz sobre la aceptación de nombres para medicamentos de uso humano autorizados mediante el procedimiento centralizado

GUIDELINE ON THE ACCEPTABILITY OF NAMES FOR HUMAN MEDICINAL PRODUCTS PROCESSED THROUGH THE CENTRALISED PROCEDURE

2.4.4. For non-prescription medicinal products, due account should be given to the specific legal status of these medicinal products as defined in Articles 71 and 72 of Directive 2001/83/EC, as amended. The use of qualifiers/abbreviations within, the (invented) name should aid selection/identification/differentiation of the product by the patient and should minimise the risk of inappropriate use. In view of the above considerations, the specific restrictive criteria described under sections 2.3.1 and 2.3.4 may not apply here. In order to help self-selection and compliance by patient/consumers, it is acceptable that (invented) names have a positive connotation and/or be informative. The applicant may consider providing the NRG with an explanation for their inclusion.

Particularidades de los nombres de los medicamentos no sujetos a prescripción (medicamentos de autocuidado), uso de abreviaturas o calificativos para diferenciarlos y favorecer el uso inapropiado o la confusión. Connotación positiva o informativa aceptable dentro del nombre de fantasía del medicamento. Justificar convenientemente.