Brinzolamide

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 can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.

The PEC (predicted environmental concentration) values used to calculate risk in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.

Brinzolamide has only undergone a phase I study according to regulatory requirements for environmental risk assessments (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.) A phase I study includes data on bioaccumulation and calculates the concentration of brinzolamide in the environment (PEC_surfacewater). If specified limit values are not exceeded, the company does not need to conduct a phase II study that includes data on toxicity and persistence and calculation of risk based on PEC/PNEC.

Assessment report for Simbrinza

Assessment report for Simbrinza (brimonidine, brinzolamide) about brinzolamide, 22 May 2014, EMA/366328/2014.

Hazard

Persistence: No data.

Bioaccumulation: OECD 107. -0.82 (pH 10).

Toxicity: No data.

Risk

PEC_surfacewater = 0.007 microg/L. Conclusion > 0.01 threshold - No.

"Therefore, based on the lower than 4.5 log K_ow value obtained (-0.82) and the PEC_surfacewater value (7 x 10^-3) which is lower than the action limit (0.01 μg/L), brinzolamide 10 mg/mL in the combination product Simbrinza is considered unlikely to represent a risk for the environment following its prescribed use."

Scientific discussion for Azopt

Scientific discussion for Azopt (brinzolamide), EMEA 2004.

"Exposure assessment estimates for the different environmental compartments have shown that, based on the methods and calculations presented in the guideline for environmental risk assessment, the concentration of brinzolamide is below the established threshold values (0.001 µg/l for water and 10 ppb for soil) for concern. There are no factors regarding the toxicity of brinzolamide that would require consideration of stricter criteria, and further investigations are not considered necessary."

Assessment report for Azarga

Assessment report for Azarga (brinzolamide, timolol) for brinzolamid, Doc.Ref.: EMEA/CHMP/643354/2008.

"Based on the estimation of exposure and calculation of the PEC (Predicted Environmental Concentration) AZARGA is unlikely to pose any perceivable risk to the environment."

Fass environmental information

Fass environmental information for Azarga about brinzolamide from Novartis (downloaded 2024-08-09).

Hazard

Persistence: No data.

Bioaccumulation: Log K_ow = 0.817 (method unknown) (Alcon Technical Report No. 136:60:0900).

Toxicity: No data.

Risk

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