Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
not specified
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Fluvoxamine Base provides the pharmacologic and toxicological propierties of this compound.
Maleate counterion is pharmacologically acceptable and not dangerous.
Thus, Fluvoxamine Base classification is based on Fluvoxamine Maleate.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
According to studies for Fluvoxamine maleate there is no evidenceof fertility impariment. Adverse effects were only seen at high doses in animal studies.
Avoid contact during pregnancy/while nursing.