Recorded active ingredients: Estradiol, Norethisteron
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Not applicable.
Animal studies with estradiol and norethisterone acetate have shown oestrogenic and progestagenic effects as expected. Both compounds induced adverse effects in preclinical reproductive toxicity studies, in particular embryotoxic effects and anomalies in urogenital tract development. Concerning other preclinic effects, the toxicity profiles of estradiol and norethisterone acetate are well-known and reveal no particular human risks beyond those discussed in other sections of the Summary of Product Characteristics and which generally apply to hormone substitution therapy.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.