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Necitumumab

Summary

Hazard - P - B - T - Risk Exempt

Assessment report

Assessment report for Portrazza (necitumumab), 17 December 2015, EMA/CHMP/15391/2016.

"Necitumumab is a protein, which is expected to biodegrade in the environment and not be a significant risk to the environment. Thus, according to the “Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use” (EMEA/CHMP/SWP/4447/00), necitumumab is exempt from preparation of an Environmental Risk Assessment as the product and excipients do not pose a significant risk to the environment."

Fass environmental information

Environmental information is missing on fass.se (2019-09-04). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

References

  1. European Medicines Agency. European public assessment reports (EPAR). Portrazza (necitumumab),17 December 2015, EMA/CHMP/15391/2016.
  2. European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006.

Author: Health and Medical Care Administration, Region Stockholm