Emgality® (Galcanezumab)

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

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Galcanezumab: Generic Name Suffix

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


Detailed Information

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


1FDA U.S. Food and Drug Administration website. Nonproprietary Naming of Biological Products Guidance for Industry. https://www.fda.gov/downloads/drugs/guidances/ucm459987.pdf. Accessed February 5, 2019.


FDA = Food and Drug Administration

Fecha de la última revisión: 2019 M02 04

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