Travoprost

Detaljerad information

Utredningsrapport

Utredningsrapport för Izba 19 december 2013, EMA/13480/2014.

Fara

Persistens: Data saknas.

Bioackumulation: Log K_ow = 4,483. "However, the study that ascertained this value was not carried out according to the criteria set out in the relevant OECD Guideline. Therefore, the log K_ow value for travoprost of 4.483 as determined in this study is questionable. In order to conclude on the exact log K_ow, its value should be determined strictly according to the guideline of the method chosen."

Toxicitet: Data saknas.

Risk

PEC = 0,009 mikrog/L. "As the PEC_surfacewater value is below the 0.01 μg/L action limit value, a Phase II environmental effect analysis is not needed. Travoprost is considered unlikely to represent a risk for the environment following its prescribed use and no further action is required under the Committee for Medicinal Products for Human Use (CHMP) “Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00)”.

Slutsats

"If the log K_ow value obtained for the product would be higher than 4.5, according to “Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00)” and “Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/44609/2010)”, travoprost should be screened by the MAH (marketing authorisation holder, red. anm.) in a step-wise procedure for persistence, bioaccumulation and toxicity." Ingen information om travoprost som belyser detta har återfunnits på EMAs webbplats. En fråga om huruvida nya data har inkommit till myndigheten mejlades till Läkemedelsverket 2020-09-07. Se svar i nästa stycke.

Underlaget för texten i produktresumén för Izba

Enligt mejl från Läkemedelsverket 2020-09-07 har inga nya data inkommit men frågan har diskuterats i Worksharing procedure EMEA/H/C/WS1385 och resonemanget från MAH var följande:

“According to the REACh guidance on PBT assessment (Guidance on information requirements and chemical safety assessment. Part C: PBT/vPvB Assessment. Version 3.0. June 2017), the applicant may choose to treat the substance ‘as if it is a PBT or vPvB’ substance on the basis of the screening assessment (see chapter C.4.2. Assessment). Only ‘if the registrant decides to further evaluate the properties of the substance’, a full assessment for PBT properties with definitive tests is required. The applicant believes that the available information is sufficient to perform the PBT assessment: the screening criteria for P and B are met as required, and criteria for toxicity is met based on the outcome of mammalian toxicity studies. Consequently, based on the screening criteria for P and B and definitive assessment criteria for T, the applicant chooses to treat the substance as PBT substance and to abstain from a definitive PBT assessment, including a definitive study on Persistence (Study on Transformation in aquatic sediment systems according to the Organization for Economic Co-operation and Development [OECD] 308). Also, in line with the ERA guidance, the requirement to perform an OECD 308 study for substances that are not readily biodegradable is stated only for Phase II Fate and Exposure Assessment. As travoprost clearly remains below the trigger level for a Phase II Fate and Exposure Assessment, this API does not fall under the requirement to perform a study following OECD 308.

The applicant accepts the PBT hazard label as a conservative, worst case hazard statement, that results in an addition of this hazard label to the SmPC.”

Resultatet blev att produktresumén för Izba uppdaterades 2018-07-26 med informationen i punkt 5.3 men också i punkt 6.6 som lyder enligt följande: "Det bör nämnas att travoprost anses vara en PBT-substans (se avsnitt 5.3)."

Fass miljöinformation

Fass miljöinformation för Izba (travoprost) från Novartis (hämtad 2020-09-07).

Fara

Persistens: "3–4%, not readily biodegradable (OECD301B)." Travoprost är potentiellt persistent.

Bioackumulation: log K_ow = 4,647 (OECD123). Travoprost har hög potential att bioackumuleras.

Toxicitet: Data saknas.

Risk

PEC = 0,0000054 mikrog/L (år 2016). Risk för miljöpåverkan av travoprost kan inte uteslutas då ekotoxikologiska data saknas.