Necitumumab
Sammanfattning
Fara - P - B - T - Risk Undantagen
Utredningsrapport
Utredningsrapport för 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 miljöinformation
Miljöinformation saknas på fass.se (2019-09-04). Det är frivilligt för tillverkare att lämna uppgifter om miljöpåverkan på fass.se.
Referenser
- European Medicines Agency. European public assessment reports (EPAR). Portrazza (necitumumab),17 December 2015, EMA/CHMP/15391/2016.
- 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.
Författad vid avdelningen Kunskapsutveckling, Region Stockholm