Lipegfilgrastim

Detailed information

Assessment report Lonquex 2013

Assessment report for Lonquex (lipegfilgrastim), Teva Pharma B.V., 30 May 2013, EMA/371234/2013.

"The Applicant has provided a suitable justification for not performing an Environmental Risk Assessment (ERA) in line with the guidance from the “Guideline on the Environmental Risk Assessment of the medicinal products for human use” (EMEA/CHMP/SWP/4447/00). Lonquex is a PEGylated recombinant protein and is unlikely to result in significant risk to the environment. No further evaluation has been provided and this is acceptable."

Assessment report Lonquex 2022

Assessment report for Longuex, Type II group of variations, Teva Pharma B.V., 23 June 2022, EMA/CHMP/642324/2022.

"Justification of absence of specific environmental risk assessment (ERA) studies in line with the EMA guideline (EMEA/CHMP/SWP/4447/00 corr 2.) was included for this extension of indication application. Lonquex is a PEGylated recombinant protein that is linked via a short carbohydrate chain and undergoes hydrolysis and proteolytic cleavage following administration. The linker components (L-Glycine, sialic acid and GalNac) are also naturally occurring substances. The PEG moiety is unlikely to result in a significant risk to the environment, because of metabolic breakdown before excretion in patients, rapid biodegradation in the environment and low toxicity. The extension of use of Lonquex to include paediatric patients is not expected to increase the overall consumption nor to increase the environmental exposure to this class of drugs. Therefore, separate ERA studies for Lonquex are not required."