Hazard - P - B - T - Risk Exempt
Assessment report for Nplate (romiplostim), 9 November 2017 EMA/302907/2018.
"The applicant justifies the ERA omission in accordance with the CHMP Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 1*, 1 June 2006). Romiplostim meets the criteriafor compounds that may be exempted from testing because of their chemical structure and constituents (amino acids and proteins) which should degrade into their amino acid or constitutive elements in the environment. The conclusion of the applicant on environmental risk assessment is accepted. This medicinal product is unlikely to result in significant risk to the environment.
Considering the above data, romiplostim is not expected to pose a risk to the environment."
Fass environmental information
Fass environmental information for Nplate from Amgen (downloaded 2019-09-02).
The use of amino acids, proteins and peptides is not considered to have any environmental impact.
- European Medicines Agency. European public assessment reports (EPAR). Nplate (romiplostim), 9 November 2017 EMA/302907/2018.
- 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.
- Fass för vårdpersonal.
Author: Health and Medical Care Administration, Region Stockholm