Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Vortioxetine

Hazard 9 P 3 B 3 T 3 Risk See below

Information

The T-value in the score for hazard refers to chronic toxicity.

According to EU established criteria, vortioxetine is considered a PBT/vPvB substance. The toxicity of aquatic organisms is very high, the substance is capable of bioaccumulation and degradation is slowly in the environment.

Assessment report

Assessment report for Brintellix (vortioxetine) 24 October 2013, EMA/699150/2013.

Hazard

Persistence: OECD 308: "DT50, water = 2.1-3.7 days, DT50, sediment = not calculable, DT50, whole system = 7.2-50.1 days % shifting to sediment (d100) = 90.7% / 86.7%"

Bioaccumulation: BCF = 2 032-2 121

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish 0.091 microg/L.

Risk

Th risk, PEC/PNEC, from assessment report is from a European perspective. "Free base; risk for fish PEC/PNEC > 1", i.e. moderate.

"The compound is considered as PBT. [---] The available data do not allow to conclude definitively on the potential risk of vortioxetine to the environment. The CHMP recommends further investigation." No further information has been found.

Fass environmental information

Environmental information is missing on fass.se (2018-06-14). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Author: Health and Medical Care Administration, Region Stockholm