Anagrelide

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.

Assessment report for Xagrid

Scientific discussion for Xagrid (anagrelide), 2007-04-24.

"An environmental assessment concluded that due to the limited patient numbers and low dose, use of anagrelide will not represent a risk to the environment and therefore no formal ecotoxicological studies have been conducted. Based on the action limit for PEC_{surface water} of 10 ng/l, anagrelide hydrochloride is unlikely to represent a risk for the environment following its prescribed usage in patients."

Assessment report for Anagrelide Mylan

Assessment report for Anagrelide Mylan,14 December 2017, EMA/63484/2018.

"No Environmental Risk Assessment was submitted. This was justified by the applicant as the introduction of Anagrelide Mylan manufactured by Mylan S.A.S is considered unlikely to result in any significant increase in the combined sales volumes for all anagrelide containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."