Tacrolimus

Detailed information

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.

EMA's "scientific discussion" for Protopic (tacrolimus), LEO Pharma A/S, 29/08/2006.

"No environmental risk is anticipated from the use of tacrolimus ointment."

EMA's "scientific discussion" for Advagraf (tacrolimus), Astellas Pharma Europe B.V., 30/05/2007.

"The environmental risk assessment of MR4 oral formulation of tacrolimus followed primarily the draft of guidelines related to this issue. From the results obtained, it is concluded that MR4 is of no immediate risk to the environment and no proposals for labelling provisions are necessary to reduce any potential environmental risks. [---] The use of Advagraf is not considered to pose a risk to the environment."

Assessment report for Modigraf (tacrolimus), Astellas Pharma Europe B.V., Doc.Ref.: EMEA/306253/2009.

"The use of tacrolimus granules is not expected to lead to any significant increase in environmental exposure. However, considering the currently applicable guideline, the potential environmental risk should be further addressed. This can be done as a follow up measure. [---] The potential environmental risk should be further addressed (FUM)." No such information has been found on the EMA's website (2021-01-19).

Assessment report for Envarsus (tacrolimus), Chiesi Farmaceutici S.p.A., 22 maj 2014, EMA/CHMP/81205/2014.

"In accordance with the Guideline on the Environmental Risk Assessment of Medicinal Products for Human use [EMEA/CHMP/SWP4447/00], a justification for the absence of an environmental risk assessment (ERA) has been provided. The applicant stated that LCP-Tacro tablets will replace similar products already marketed in the European Union/European Economic Area. Thus, an increase of the environmental exposure is not expected with this medicinal product. The justification was considered acceptable by the CHMP."

Fass environmental information

Fass environmental information for Modigraf from Astellas Pharma (downloaded 2021-01-19).

Hazard

Persistence: No data.

Bioaccumulation: No data.

Toxicity: No data.

Risk

PEC is based on sales data in Sweden in year 2016. PEC = 0.0016 μg/L