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Vernakalant

Summary

Persistence. It cannot be excluded that vernakalant is persistent, due to lack of data.

Bioaccumulation. Vernakalant has low potential for bioaccumulation.

Toxicity. It cannot be excluded that vernakalant is toxic, due to lack of data.

Risk. Risk of environmental impact of vernakalant cannot be excluded, due to the lack of environmental toxicity data.

 

This summary information comes from assessment report. See further under the heading "Detailed information" and the comment regarding assessment reports and phase I environmental studies conducted for vernakalant.

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

Assessment report

Assessment report for Brinavess (vernakalant), Merck Sharp & Dohme Ltd., Procedure No. EMEA/H/C/001215, 2010-09-28.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow < 4,5. No value for Log Kow is provided.

Toxicity: No data.

Risk

"Using this Fpen and the dose of 453 mg/patient/day, PECsurface water = 9.5 ng/L, which is below the trigger value it was considered that a further assessment is not deemed necessary."

Comment

Vernakalant has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of vernakalant (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.

References

  1. European Medicines Agency. European public assessment report (EPAR) for Brinavess (vernakalant), Merck Sharp & Dohme Ltd., Procedure No. EMEA/H/C/001215, 2010-09-28.

Author: Health and Medical Care Administration, Region Stockholm