Romiplostim
Sammanfattning
Fara - P - B - T - Risk Undantagen
Utredningsrapport
Utredningsrapport för Nplate (romiplostim), 9 November 2017 EMA/302907/2018.
Risk
"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 miljöinformation
Fass miljöinformation för Nplate från Amgen (hämtad 2019-09-02).
Risk
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
Referenser
- 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.
Författad vid avdelningen Kunskapsutveckling, Region Stockholm