Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Galcanezumab: Generic Name Suffix

The suffix "gnlm" added to galcanezumab does not have any clinical meaning.

MX_cFAQ_GLC011_GENERIC_NAME_SUFFIX
MX_cFAQ_GLC011_GENERIC_NAME_SUFFIX
es-MX

Detailed Information

The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country.

The suffix assigned to galcanezumab, -gnlm, is an FDA-designated suffix applicable in the United States only. The FDA issued guidance in 2017 regarding the addition of 4-letter suffixes to the end of the core name of newly approved biologics.1 

The suffixes

  • are unique to each core name
  • have no meaning
  • consist of 4 lower-case letters of which at least 3 are distinct
  • are non-proprietary
  • are attached to the core name via hyphen, and
  • are free from usage-restricting legal barriers.1

According to the FDA, the suffix can

  • serve as a key element to identify specific products in spontaneous adverse event reporting
  • help to avoid the inaccurate perception of safety and efficacy based on licensure pathway
  • minimize inadvertent substitutions that are not interchangeable, and
  • reinforce accurate product identification in prescribing, billing, and claims records used for active pharmacovigilance.1

References

1US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Nonproprietary naming of biological products: guidance for industry. January 2017. Accessed July 29, 2020. https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf

Glossary

FDA = Food and Drug Administration

Fecha de la última revisión: 2019 M02 04


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