Pramipexole

Detailed information

Fass environmental information

Fass environmental information for Mirapexin (pramipexol) from Boehringer Ingelheim (downloaded 2023-03-01).

Hazard

Persistence: Aerobic degradation (US-FDA, TAD 3.11) ... 3.5% mineralization in 28 days 80% primary degradation in 28 days (estimated 50% degradation in 17 days).

Aquatic photodegradation half-life ...
pH 5 = 346 hours
pH 7 = 55,5 hours
pH 9 = 33,1 hours

Justification: Pramipexole is degraded photolytically over the range of pH likely to be encountered in the environment indicating that it is readily degraded. However although the aerobic degradation results indicate that significant biodegradation did occur, as 80% of the compound was degraded during the test period, significant mineralization did not occur and pramipexole did not pass the 10 day criteria. The phrase “Pramipexole is potentially persistent” is therefore used.

Bioaccumulation: OECD 107: pH 7 : log D = -1,0. "Justification: Since log D < 4 at pH 7, “Pramipexole has low potential for bioacculumation."

Acute toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) (OECD 202) EC₅₀ 48 h (immobilization) 70 000 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.00001 which gives the risk insignificant.

Assessment report Oprymea

Assessment report for Oprymea (pramipexole) 19 September 2013, EMA/703661/2013.

"No Environmental Risk Assessment (ERA) was submitted. This was justified by the applicant as the introduction of Oprymea manufactured by Krka d.d. Novo mesto is considered unlikely to result in any significant increase in the combined sales volumes for all parmipexole containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."

Assessment report Pramipexole Accord

Assessment report for Pramipexole Accord, London, 21 July 2011, EMA/816841/2011.

"No Environmental Risk Assessment (ERA) was submitted. This was justified by the applicant as the introduction of Pramipexole Accord manufactured by Accord Healthcare Limited is considered unlikely to result in any significant increase in the combined sales volumes for all pramipexole containing products and the exposure of the environment to the active substance. Thus, the ERA is expected to be similar and not increased."

Comment on environmental information on EMA's website

However, no environmental information about pramipexole has been found on the EMA website (2023-03-01).