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Cerdelga

Sanofi AB

Kapsel, hård 84 mg
(blågrön pärlemorskimrande, opak överdel och pärlemorsvit, opak underdel med “GZ02” tryckt i svart, storlek 18,0 * 6,4 mm)

Medel för matsmältning och ämnesomsättning

Aktiv substans:
ATC-kod: A16AX10
Utbytbarhet: Ej utbytbar
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Eliglustat

Miljörisk: Risk för miljöpåverkan av eliglustat kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att eliglustat är persistent, då data saknas.
Bioackumulering: Eliglustat har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental Risk Classification

Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A*(100-R)

PEC = 0.000014 µg/L


Where:

A = 0,0941 kg (total sold amount API in Sweden year 2017, data from IQVIA)

R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9*106

V (L/day) = volume of wastewater per capita and day = 200 (Ref I)

D = factor of dilution of waste water by surface water flow = 10 (Ref I)


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of eliglustat is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 µg/L.


Predicted No Effect Concentration (PNEC)
Ecotoxicological studies: No data available. Since it is not possible to calculate the environmental risk classification (PEC/PNEC ratio), the summary phrase for the environmental risk is: "Risk of environmental impact of eliglustat cannot be excluded, since no ecotoxicity data are available."


Degradation

No data available. Therefore, the summary phrase for degradation to be used is: ”The potential for persistence of eliglustat cannot be excluded, due to lack of data”.


Bioaccumulation

Partitioning coefficient

Log Kow = 2.84 (potentiometric method, pH unknown) (Ref II).


Justification of chosen bioaccumulation phrase:

Since log Kow < 4, eliglustat has low potential for bioaccumulation (Ref II).


Excretion

No data available.


Reference

I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.

II: Cerdelga - Assessment report for an initial marketing authorisation application. 20 November 2014. Retrieved March 28, 2019, from https://www.ema.europa.eu/en/documents/assessment-report/cerdelga-epar-public-assessment-report_en.pdf