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Hazard - P - B - T - Risk Exempt


Underlying data for risk is from assessment reports.

Assessment report

Assessment report for Taltz (ixekizumab) 25 February 2016 EMA/CHMP/190631/2016.

"Ixekizumab is a monoclonal anti-human Interleukin-17A antibody and therefore in accordance with the CHMP guideline on the environmental risk assessment (EMEA/CHMP/SWP/4447/00) is exempt of the need for an environmental risk assessment."

Assessment report for Taltz 14 December 2017 EMA/59447/2018.

"The MAH (marketing authorisation holder, ed. note) submitted a justification for not submitting any ERA studies since the product is a human antibody. This is acceptable by CHMP. [...] Ixekizumab is not expected to pose a risk to the environment."

Fass environmental information

Environmental information is missing on fass.se (2020-02-21). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Author: Health and Medical Care Administration, Region Stockholm